NR Line
303 catalogue numbers from GBAB3520, listed by Dentium Co., Ltd., South Korea, under Abutment, Implant, Dental, Endosseous. 15 manufacturers in China are registered for this product code.
15manufacturers in China registered for this device type
303catalogue numbers in this listing
13510(k) clearances naming this product code
Who Else Makes It
Concentrated in Guangdong (11), Jiangsu (2), Shanghai (1). 10 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Modern Dental Laboratory (DG) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 15 |
| Exceldent Dental Technology Development Co., Ltd. | Zhuhai | Guangdong | Contract manufacturer | 12 |
| DTS Digital Dental LAB | Shenzhen | Guangdong | Contract manufacturer | 11 |
| KTJ Medical Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 11 |
| Shimmer Computerized Dental Technology Co., Ltd. | Zhuhai | Guangdong | Contract manufacturer | 10 |
| Zhuhai Crystal Dental Technology Co., Ltd. | Zhuhai | Guangdong | Contract manufacturer | 9 |
| NEW Perfect Dental LAB | Shenzhen | Guangdong | Contract manufacturer | 8 |
| Shenzhen Jiahong Dental Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 7 |
| Jiangsu Trausim Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 3 |
| Chengdu Besmile Medical Technology Co., Ltd. | Chengdu | Sichuan | Manufacturer | 14 |
| CBD Dental LAB, Inc | Shenzhen | Guangdong | Manufacturer | 11 |
Showing 12 of 15. All 15 manufacturers in China registered for Abutment, Implant, Dental, Endosseous
Record
| Listed by | Dentium Co., Ltd., South Korea |
|---|---|
| FDA product code | NHA |
| Device type | Abutment, Implant, Dental, Endosseous |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3630 |
| Establishment | Manufacturer |
| 510(k) | K153268 |
| Record published | 2016-09-24 |
| Record revised | 2019-11-08 (version 5) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Sizes | Outer diameter 1.9 to 15 mm; length 2.9 to 16.52 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| GBAB3520 | Outer Diameter 3.5 mm | In distribution |
| GAOB4320A | Outer Diameter 4.3 mm | In distribution |
| GSAB5005BA | Length 7.76 mm | In distribution |
| GAAB153730AR | Length 14.94 mm | In distribution |
| GBHA3605 | Outer Diameter 3.6 mm | In distribution |
| GIHAB6010S | G/H: 3.5 Millimeter | In distribution |
| GAOB432010AS | Length 5.97 mm | In distribution |
| GRAB37CS | Length 7.92 mm | In distribution |
| GDAB5520AR | Length 10.92 mm | In distribution |
| GDAB6550AS(H) | G/H: 5.0 Millimeter | In distribution |
| GDAB4340AS | Length 12.92 mm | In distribution |
| GAOB4310A | Outer Diameter 4.3 mm | In distribution |
| BPF2 | Outer Diameter 4.85 mm | In distribution |
| GDAB3720AS | Outer Diameter 3.7 mm | In distribution |
| GMAB4310AS | Outer Diameter 4.3 mm | In distribution |
| GAAB154320AS | Length 14.03 mm | In distribution |
| GHAB555565 | Outer Diameter 5.5 mm | In distribution |
| GHAB650530 | Length 8.6 mm | In distribution |
| GBAB3550 | Length 13.5 mm | In distribution |
| GDAB5550AR(H) | Outer Diameter 5.5 mm | In distribution |
| GAAB253720AS | Length 13.93 mm | In distribution |
| GAAB253710AR | Outer Diameter 3.7 mm | In distribution |
| GDAB4350AR(H) | G/H: 5.0 Millimeter | In distribution |
| GDAB5550AS | Outer Diameter 5.5 mm | In distribution |
| GIHAB5010TS | G/H: 3.5 Millimeter | In distribution |
| GHAB373545 | Length 10.1 mm | In distribution |
| GIHAB6010R | G/H: 3.5 Millimeter | In distribution |
| GDAB6520AR | Outer Diameter 6.5 mm | In distribution |
| GCMAB20S | In distribution | |
| GDAB5530AR(H) | Outer Diameter 5.5 mm | In distribution |
| GDAB5540AR | Length 12.92 mm | In distribution |
| GDAB4350AR | Length 13.92 mm | In distribution |
| GDAB4310AR | Length 9.92 mm | In distribution |
| GAOB4330A | Length 7.1 mm | In distribution |
| GDAB3720AR | Length 10.92 mm | In distribution |
| GSRS16T | Outer Diameter 1.9 mm | In distribution |
| GIHAB5010TR | G/H: 3.5 Millimeter | In distribution |
| GDAB4310AS(H) | G/H: 1.0 Millimeter | In distribution |
| GIHAB6010TR | Outer Diameter 6 mm | In distribution |
| GDAB3720AS(H) | G/H: 2.0 Millimeter | In distribution |
| GDAB6550AR | Length 13.42 mm | In distribution |
| GMAB3710AR | Length 15.42 mm | In distribution |
| GDAB3730AS(H) | Outer Diameter 3.7 mm | In distribution |
| GAOB432030AR | Length 7.37 mm | In distribution |
| GHAB650530 | Outer Diameter 6.5 mm | In distribution |
| GHAB371525 | Outer Diameter 3.7 mm | In distribution |
| GDAB4305BAS | Length 9.42 mm | In distribution |
| GDAB4330AR | Outer Diameter 4.3 mm | In distribution |
| GHAB371525 | Length 8.1 mm | In distribution |
| GAAB255520AR | Length 14.47 mm | In distribution |
| GIHAB4010TS | Outer Diameter 4 mm | In distribution |
| GSTA50A | Length 6 mm | In distribution |
| GDAB5550AR | Length 13.92 mm | In distribution |
| GDAB6505BAR | Length 8.92 mm | In distribution |
| GMAB4320AR | Outer Diameter 4.3 mm | In distribution |
| GMAB6510AR | Outer Diameter 6.5 mm | In distribution |
| GDAB3710AR | Outer Diameter 3.7 mm | In distribution |
| GDAB5530AS | Outer Diameter 5.5 mm | In distribution |
| GDAB5530AS(H) | G/H: 3.0 Millimeter | In distribution |
| GIHAB6006TR | G/H: 2.5 Millimeter | In distribution |
| GRAB43CS | Outer Diameter 4.3 mm | In distribution |
| GMAB5530AR | Length 15.42 mm | In distribution |
| GMAB3720AR | Length 15.42 mm | In distribution |
| GMAB5510AR | Length 15.42 mm | In distribution |
| GIHAB5008R | G/H: 3.0 Millimeter | In distribution |
| GDAB6540AR | Outer Diameter 6.5 mm | In distribution |
| GDAB6540AR(H) | Outer Diameter 6.5 mm | In distribution |
| GHAB553545 | Outer Diameter 5.5 mm | In distribution |
| GAOS5010A | Length 3.86 mm | In distribution |
| GCMAB15ARS | Outer Diameter 15 mm | In distribution |
| GDAB6520AR(H) | G/H: 2.0 Millimeter | In distribution |
| GCMAB14AS | Outer Diameter 14 mm | In distribution |
| GDAB4305BAS(H) | Outer Diameter 4.3 mm | In distribution |
| GCMAB10ARS | Outer Diameter 10 mm | In distribution |
| GIHAB6006R | Outer Diameter 6 mm | In distribution |
| GAAB153720AR | Length 13.94 mm | In distribution |
| GDAB6540AS(H) | Outer Diameter 6.5 mm | In distribution |
| GCS30 | Outer Diameter 3.1 mm | In distribution |
| GAOB432010AR | Outer Diameter 4.3 mm | In distribution |
| GIHAB4008TR | G/H: 3.0 Millimeter | In distribution |
| GDAB5520AS | Length 10.92 mm | In distribution |
| GAAB253730AS | Length 14.93 mm | In distribution |
| GDAB4310AR(H) | G/H: 1.0 Millimeter | In distribution |
| GAAB154330AS | Length 15.03 mm | In distribution |
| GDAB5505BAS | Outer Diameter 5.5 mm | In distribution |
| GDAB3740AS(H) | G/H: 4.0 Millimeter | In distribution |
| GCMAB10AR | Outer Diameter 10 mm | In distribution |
| GRAB43CR | Length 7.92 mm | In distribution |
| GAAB253710AS | Length 12.93 mm | In distribution |
| GSTC50AT | Length 12 mm | In distribution |
| GMAB5510AS | Outer Diameter 5.5 mm | In distribution |
| GAAB254330AS | Outer Diameter 4.3 mm | In distribution |
| GAAB154330AR | Length 15.03 mm | In distribution |
| GCMAB30SS | In distribution | |
| GHAB954040 | Outer Diameter 9.5 mm | In distribution |
| GHAB854040 | Length 10.1 mm | In distribution |
| GDAB4350AS | Length 13.92 mm | In distribution |
| GAOS5020A | Length 4.86 mm | In distribution |
| GIHAB6008TR | G/H: 3.0 Millimeter | In distribution |
| GMAB3730AS | Outer Diameter 3.7 mm | In distribution |
| GIHAB4006S | G/H: 2.5 Millimeter | In distribution |
| GHAB754040 | Outer Diameter 7.5 mm | In distribution |
| GHAB655565 | Length 12.1 mm | In distribution |
| GIHAB6006TS | Outer Diameter 6 mm | In distribution |
| GDAB5520AR(H) | G/H: 2.0 Millimeter | In distribution |
| GDAB5530AR | Length 11.92 mm | In distribution |
| GAAB153720AS | Outer Diameter 3.7 mm | In distribution |
| GDAB4330AS(H) | Outer Diameter 4.3 mm | In distribution |
| GDAB3740AR | Length 12.92 mm | In distribution |
| GHAB651525 | Length 8.1 mm | In distribution |
| GDAB4340AS(H) | G/H: 4.0 Millimeter | In distribution |
| GIHAB5008TR | G/H: 3.0 Millimeter | In distribution |
| GSAB5030A | Length 10.26 mm | In distribution |
| GAAB154310AR | Length 13.03 mm | In distribution |
| GCMAB30R | In distribution | |
| GCMAB30S | In distribution | |
| GSAB5010A | Length 8.26 mm | In distribution |
| GIHAB5008S | Outer Diameter 5 mm | In distribution |
| GMAB6520AS | Outer Diameter 6.5 mm | In distribution |
| GHAB435565 | Length 12.1 mm | In distribution |
| GIHAB5006R | G/H: 2.5 Millimeter | In distribution |
| GAAB255530AR | Outer Diameter 5.5 mm | In distribution |
| GDAB4340AR(H) | G/H: 4.0 Millimeter | In distribution |
| GHAB375565 | Outer Diameter 3.7 mm | In distribution |
| GHAB651525 | Outer Diameter 6.5 mm | In distribution |
| GASC1619 | Length 8.15 mm | In distribution |
| GDAB6540AS | Outer Diameter 6.5 mm | In distribution |
| GDAB3730AR(H) | Outer Diameter 3.7 mm | In distribution |
| GBHA3135 | Outer Diameter 3.16 mm | In distribution |
| GHAB550530 | Length 8.6 mm | In distribution |
| GIHAB6010TS | G/H: 3.5 Millimeter | In distribution |
| GHAB435565 | Outer Diameter 4.3 mm | In distribution |
| GHAB854040 | Length 10.1 mm | In distribution |
| GAAB254310AS | Outer Diameter 4.3 mm | In distribution |
| GDAB6530AS | Length 11.42 mm | In distribution |
| GCMAB10AS | Outer Diameter 10 mm | In distribution |
| GHAB551525 | Length 8.1 mm | In distribution |
| GRAB37TS | Length 16.52 mm | In distribution |
| GIHAB6006S | Outer Diameter 6 mm | In distribution |
| GDAB5550AS(H) | Outer Diameter 5.5 mm | In distribution |
| GDAB4310AS | Outer Diameter 4.3 mm | In distribution |
| GAOSC1619 | Length 6.15 mm | In distribution |
| GDAB5505BAR | Outer Diameter 5.5 mm | In distribution |
| GHAB553545 | Length 10.1 mm | In distribution |
| GDAB3720AR(H) | Outer Diameter 3.7 mm | In distribution |
| GDAB4320AS(H) | G/H: 2.0 Millimeter | In distribution |
| GAAB255510AR | Outer Diameter 5.5 mm | In distribution |
| GCMAB14ARS | Outer Diameter 14 mm | In distribution |
| GHAB655565 | Outer Diameter 6.5 mm | In distribution |
| GHAB431525 | Length 8.1 mm | In distribution |
| GIHAB4008TS | G/H: 3.0 Millimeter | In distribution |
| GAAB153710AR | Length 12.94 mm | In distribution |
| GHAB430530 | Length 8.6 mm | In distribution |
| GSBC50 | Outer Diameter 5 mm | In distribution |
| GDAB6510AR | Length 9.42 mm | In distribution |
| GMAB6530AS | Length 15.42 mm | In distribution |
| GIHAB4010R | G/H: 3.5 Millimeter | In distribution |
| GDAB5510AR | Length 9.92 mm | In distribution |
| GAAB155520AR | Outer Diameter 5.5 mm | In distribution |
| GDAB5505BAS(H) | Outer Diameter 5.5 mm | In distribution |
| GMAB5520AS | Outer Diameter 5.5 mm | In distribution |
| GAAB155520AS | Length 14.26 mm | In distribution |
| GDAB3705AS | Length 9.42 mm | In distribution |
| GAAB154310AS | Length 13.03 mm | In distribution |
| GAAB153730AS | Length 14.94 mm | In distribution |
| GDAB4320AR | Length 10.92 mm | In distribution |
| GAAB254320AS | Length 14.09 mm | In distribution |
| GHAB954040 | Length 10 mm | In distribution |
| GDAB3705AR(H) | G/H: 0.5 Millimeter | In distribution |
| GIHAB6008TS | G/H: 3.0 Millimeter | In distribution |
| GMAB6530AR | Length 15.42 mm | In distribution |
| GIHAB6008R | Outer Diameter 6 mm | In distribution |
| GMAB6520AR | Length 15.42 mm | In distribution |
| GDAB3750AR(H) | G/H: 5.0 Millimeter | In distribution |
| GAAB155530AR | Outer Diameter 5.5 mm | In distribution |
| GHAB430530 | Outer Diameter 4.3 mm | In distribution |
| GMAB4330AS | Length 15.42 mm | In distribution |
| GIHAB4008S | G/H: 3.0 Millimeter | In distribution |
| GAAB155530AS | Length 15.26 mm | In distribution |
| GRAB43TR | Outer Diameter 4.3 mm | In distribution |
| GDAB6550AR(H) | G/H: 5.0 Millimeter | In distribution |
| GDAB6505BAR(H) | G/H: 0.5 Millimeter | In distribution |
| BPF3 | Outer Diameter 4.05 mm | In distribution |
| GBAB3540 | Outer Diameter 3.5 mm | In distribution |
| GIHAB4010TR | Outer Diameter 4 mm | In distribution |
| GDAB4330AR(H) | Outer Diameter 4.3 mm | In distribution |
| GHAB431525 | Outer Diameter 4.3 mm | In distribution |
| GHAB375565 | Length 12.1 mm | In distribution |
| GAOB432020AR | Length 6.69 mm | In distribution |
| GHAB551525 | Outer Diameter 5.5 mm | In distribution |
| GHAB370530 | Length 8.6 mm | In distribution |
| GDAB3750AS | Length 13.92 mm | In distribution |
| GCS36 | Outer Diameter 3.5 mm | In distribution |
| GHAB653545 | Length 10.1 mm | In distribution |
| GCS30 | Length 5.02 mm | In distribution |
| GCMAB10ASS | Outer Diameter 10 mm | In distribution |
| GAAB155510AR | Length 13.26 mm | In distribution |
| GBAB3510 | Outer Diameter 3.5 mm | In distribution |
| GAAB255520AS | Length 14.47 mm | In distribution |
| GDAB6530AR | Outer Diameter 6.5 mm | In distribution |
| GDAB5540AR(H) | Outer Diameter 5.5 mm | In distribution |
| GIHAB4006R | G/H: 2.5 Millimeter | In distribution |
| GMAB4310AR | Outer Diameter 4.3 mm | In distribution |
| GAAB254320AR | Outer Diameter 4.3 mm | In distribution |
| GBAB3530 | Length 11.5 mm | In distribution |
| GHAB433545 | Length 10.1 mm | In distribution |
| GMAB6510AS | Length 15.42 mm | In distribution |
| GHAB550530 | Length 8.6 mm | In distribution |
| GMAB3720AS | Length 15.42 mm | In distribution |
| GBHA3135 | Length 9.1 mm | In distribution |
| GDAB4330AS | Outer Diameter 4.3 mm | In distribution |
| GDAB3750AS(H) | G/H: 5.0 Millimeter | In distribution |
| GAAB155510AS | Outer Diameter 5.5 mm | In distribution |
| GSAB5020A | Length 9.26 mm | In distribution |
| GDAB5510AS(H) | G/H: 1.0 Millimeter | In distribution |
| GDAB5510AR(H) | G/H: 1.0 Millimeter | In distribution |
| GDAB3710AR(H) | Outer Diameter 3.7 mm | In distribution |
| GDAB4305BAR(H) | Outer Diameter 4.3 mm | In distribution |
| GDAB3705AS(H) | G/H: 0.5 Millimeter | In distribution |
| GDAB6510AS(H) | Outer Diameter 6.5 mm | In distribution |
| GCMAB20R | In distribution | |
| GIHAB4006TR | G/H: 2.5 Millimeter | In distribution |
| GCMAB14ASS | Outer Diameter 14 mm | In distribution |
| GAAB254330AR | Outer Diameter 4.3 mm | In distribution |
| GMAB5520AR | Length 15.42 mm | In distribution |
| GCMAB30RS | In distribution | |
| GCMAB15ASS | Outer Diameter 15 mm | In distribution |
| GIHAB5010S | Outer Diameter 5 mm | In distribution |
| GDAB6505BAS(H) | G/H: 0.5 Millimeter | In distribution |
| GRAB37CR | Outer Diameter 3.7 mm | In distribution |
| GHAB373545 | Outer Diameter 3.7 mm | In distribution |
| GAOC5020A | Length 4.2 mm | In distribution |
| GAAB253730AR | Outer Diameter 3.7 mm | In distribution |
| GDAB6520AS(H) | Outer Diameter 6.5 mm | In distribution |
| GMAB4330AR | Length 15.42 mm | In distribution |
| GDAB3730AS | Length 11.92 mm | In distribution |
| GSGC50C | Length 12 mm | In distribution |
| GDAB6530AS(H) | G/H: 3.0 Millimeter | In distribution |
| GIHAB4010S | G/H: 3.5 Millimeter | In distribution |
| GDAB5520AS(H) | G/H: 2.0 Millimeter | In distribution |
| GDAB3750AR | Length 13.92 mm | In distribution |
| GDAB6510AS | Length 9.42 mm | In distribution |
| GAAB255530AS | Outer Diameter 5.5 mm | In distribution |
| GDAB3730AR | Outer Diameter 3.7 mm | In distribution |
| GCMAB14AR | Outer Diameter 14 mm | In distribution |
| GMAB5530AS | Length 15.42 mm | In distribution |
| GIHAB4006TS | Outer Diameter 4 mm | In distribution |
| GAOB432020AS | Length 6.69 mm | In distribution |
| GIHAB5006S | G/H: 2.5 Millimeter | In distribution |
| GDAB3705AR | Outer Diameter 3.7 mm | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| MEDENTiKA | Medentika GmbH | 2,553 |
| LW Vis Abutment | Ossvis Co., Ltd. | 2,520 |
| Dess dental smart solutions | Terrats Medical SL | 1,715 |
| Locator | Zest Anchors, LLC | 1,643 |
| NobelProcera® | Nobel Biocare AB | 1,526 |
| Azure | Terrats Medical SL | 1,360 |
| Neodent | Jjgc Indústria e Comércio de Materiais Dentários S.A. | 1,308 |
| LW Vis Abutment SET | Ossvis Co., Ltd. | 1,260 |
| Abutment, Implant, Dental, Endosseous | Southern Implants (PTY) Ltd | 1,240 |
| Healing Abutment | Megagen Implant Co., Ltd. | 1,218 |
| Chaorum Implant System | Medimecca Co Ltd | 1,084 |
| OT Equator | Rhein 83 SRL | 1,051 |
Showing 12 of 6,204. All products under Abutment, Implant, Dental, Endosseous
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K192436 | 2020-01-23 |
| K191634 | 2019-11-04 |
| K172640 | 2018-05-14 |
| K171622 | 2018-01-11 |
| K170384 | 2017-08-17 |
| K161713 | 2016-12-16 |
| K160828 | 2016-09-15 |
| K160483 | 2016-08-05 |
| K141457 | 2014-11-12 |
| K112045 | 2012-01-26 |
| K070228 | 2007-11-20 |
| K052957 | 2006-07-27 |
| K052823 | 2006-02-21 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.