Nobilium
Primotec Phaser/Laserwire
24manufacturers in China registered for this device type
239catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Guangdong (11), Jiangsu (7), Shanghai (2). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Digital Dental Depot | Zhuhai | Guangdong | Contract manufacturer | 17 |
| Shenzhen Jiahong Dental Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 7 |
| Wuxi Lyusmile IMP AND EXP Co., Ltd. | Wuxi | Jiangsu | Private-label distributor | 66 |
| Shanghai Smedent Medical Instrument Co., Ltd. | Shanghai | Shanghai | Repacker / relabeller | 30 |
| Fseven Dental Technology Zhuhai Co., Ltd. | Zhuhai | Guangdong | Manufacturer | 18 |
| Shenzhen Sunmc Dental Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 17 |
| Shen FU Arts LAB | Shen Zhen | Guangdong | Manufacturer | 15 |
| Shenzhen HLD Dental&Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 14 |
| Shenzhen Times Dental LAB | Shenzhen | Guangdong | Manufacturer | 13 |
| Qinhuangdao Audental Metal Technology Co., Ltd. | Qinhuangdao | Hebei | Manufacturer | 11 |
| Smile Dental Laboratory Company Limited | Zhuhai | Guangdong | Manufacturer | 11 |
| Riton 3D Technology Co., Ltd. | Guangzhou | Guangdong | Repacker / relabeller | 9 |
Showing 12 of 24. All 24 manufacturers in China registered for Alloy, Metal, Base
Record
| Listed by | Cmp Industries, LLC, United States |
|---|---|
| FDA product code | EJH |
| Device type | Alloy, Metal, Base |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3710 |
| Premarket notification | Exempt |
| Record published | 2016-11-08 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number |
| Distribution end date | 2016-11-08 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 0101S | In distribution | |
| T-4 | In distribution | |
| 0307 | In distribution | |
| 0012 | In distribution | |
| 0009K25P | In distribution | |
| PW035 | In distribution | |
| 0011GB | In distribution | |
| 801049K | In distribution | |
| 0107S | In distribution | |
| 0012SGB | In distribution | |
| 0030 | In distribution | |
| P101 | In distribution | |
| 61622 | In distribution | |
| EQB3 | In distribution | |
| 0012S | In distribution | |
| 0412 | In distribution | |
| 6015K | In distribution | |
| 6015 | In distribution | |
| 801051K | In distribution | |
| 0401-5 | In distribution | |
| 0413-5 | In distribution | |
| 804001 | In distribution | |
| 0015 | In distribution | |
| 0129C | In distribution | |
| 100013S | In distribution | |
| 0007 | In distribution | |
| 802004K8 | In distribution | |
| 6075 | In distribution | |
| 0045-25K | In distribution | |
| 6074 | In distribution | |
| 61620 | In distribution | |
| 0414 | In distribution | |
| 0124W | In distribution | |
| 0101NK | In distribution | |
| 0011 | In distribution | |
| P8S12 | In distribution | |
| T4-5 | In distribution | |
| 0307 | In distribution | |
| 0040K25 | In distribution | |
| 0020K25 | In distribution | |
| 804001K | In distribution | |
| P10112 | In distribution | |
| 809020K | In distribution | |
| EQB1 | In distribution | |
| 0124 | In distribution | |
| 804003K25 | In distribution | |
| 0100S | In distribution | |
| EQJ1 | In distribution | |
| P6S12 | In distribution | |
| 10015S | In distribution | |
| 0020SGB | In distribution | |
| 6015WK | In distribution | |
| T3K | In distribution | |
| 0020GB | In distribution | |
| 0124GB | In distribution | |
| 0016 | In distribution | |
| 0010S | In distribution | |
| 802004K25 | In distribution | |
| 801052K | In distribution | |
| TC-5 | In distribution | |
| 0102 | In distribution | |
| 62185 | In distribution | |
| 726-3209 | In distribution | |
| 802003B | In distribution | |
| 0050K | In distribution | |
| 0107K | In distribution | |
| 0410S | In distribution | |
| 61621N | In distribution | |
| 804004K | In distribution | |
| T-3 | In distribution | |
| 61620SID | In distribution | |
| 804009 | In distribution | |
| 0009 | In distribution | |
| 61622N | In distribution | |
| 808060 | In distribution | |
| 804004 | In distribution | |
| P100BF12 | In distribution | |
| 0020 | In distribution | |
| 105 | In distribution | |
| 0407 | In distribution | |
| 0124CA | In distribution | |
| P6L12 | In distribution | |
| 61621 | In distribution | |
| EQB2 | In distribution | |
| 61617K | In distribution | |
| 0100NK | In distribution | |
| 0124C | In distribution | |
| 62144 | In distribution | |
| 802002K | In distribution | |
| 6015GB | In distribution | |
| P100-25 | In distribution | |
| T4K-25 | In distribution | |
| 726-8322 | In distribution | |
| P10L12 | In distribution | |
| PW025 | In distribution | |
| 0410 | In distribution | |
| PW050 | In distribution | |
| 0013 | In distribution | |
| 61592A | In distribution | |
| 802002 | In distribution | |
| 809020S | In distribution | |
| 0020KC25 | In distribution | |
| 0003 | In distribution | |
| P8L12 | In distribution | |
| 0129GB | In distribution | |
| 804009-5 | In distribution | |
| 0308 | In distribution | |
| TC-5S | In distribution | |
| 0408S | In distribution | |
| 0127 | In distribution | |
| 0419 | In distribution | |
| 6020 | In distribution | |
| 0124-25CA | In distribution | |
| 0419GB | In distribution | |
| 0104 | In distribution | |
| 61744 | In distribution | |
| T3-250 | In distribution | |
| 0417-5 | In distribution | |
| 0417 | In distribution | |
| 0408GB | In distribution | |
| 0040K | In distribution | |
| 61619S | In distribution | |
| 0008 | In distribution | |
| 0107 | In distribution | |
| 0414-5 | In distribution | |
| 0009K | In distribution | |
| 0011NK | In distribution | |
| 726-3210 | In distribution | |
| 0108 | In distribution | |
| 804004K25 | In distribution | |
| 801050K | In distribution | |
| T3S | In distribution | |
| 0045S | In distribution | |
| 0401K-25 | In distribution | |
| 0408W | In distribution | |
| 0102NK | In distribution | |
| 61617GB | In distribution | |
| 801046LS | In distribution | |
| 0013K25 | In distribution | |
| 804009K | In distribution | |
| 0014K25 | In distribution | |
| 801002K | In distribution | |
| 62183 | In distribution | |
| 726-1298 | In distribution | |
| 0020KC | In distribution | |
| 61619GB | In distribution | |
| 611592N | In distribution | |
| 0129 | In distribution | |
| 0224S | In distribution | |
| 804003K5 | In distribution | |
| 0101K25 | In distribution | |
| 61623N | In distribution | |
| T3K-25 | In distribution | |
| 61619 | In distribution | |
| 61619SID | In distribution | |
| 0009BR | In distribution | |
| 61592 | In distribution | |
| 0010NK | In distribution | |
| 0414CA | In distribution | |
| 0020K | In distribution | |
| 0040 | In distribution | |
| 804004-5 | In distribution | |
| 61617 | In distribution | |
| 0305 | In distribution | |
| 61624N | In distribution | |
| 0006 | In distribution | |
| 61620N | In distribution | |
| 0011P | In distribution | |
| EQC3 | In distribution | |
| 0013NK | In distribution | |
| 0414GB | In distribution | |
| T-9 | In distribution | |
| 802002-25 | In distribution | |
| 0015K25 | In distribution | |
| 804009K25 | In distribution | |
| 0401 | In distribution | |
| 61623 | In distribution | |
| T4K | In distribution | |
| 802002K25 | In distribution | |
| EQC4 | In distribution | |
| 0414-5CA | In distribution | |
| 0401K | In distribution | |
| 61619N | In distribution | |
| EQL2 | In distribution | |
| 801002K5 | In distribution | |
| P101-25 | In distribution | |
| 61619W | In distribution | |
| EQC5 | In distribution | |
| 0009K25 | In distribution | |
| 804001-5 | In distribution | |
| 0015NK25 | In distribution | |
| 92001 | In distribution | |
| P100 | In distribution | |
| 10023S | In distribution | |
| 106 | In distribution | |
| T9K | In distribution | |
| 808001 | In distribution | |
| 726-3208 | In distribution | |
| 808061 | In distribution | |
| 920210 | In distribution | |
| 804001K25 | In distribution | |
| 0014S | In distribution | |
| EQC6 | In distribution | |
| 801048K | In distribution | |
| EQK1 | In distribution | |
| 0129-25 | In distribution | |
| 804003 | In distribution | |
| 0100 | In distribution | |
| 0101 | In distribution | |
| 0020S | In distribution | |
| 0108-25 | In distribution | |
| 0106 | In distribution | |
| 0127-25 | In distribution | |
| 801002 | In distribution | |
| 804003K | In distribution | |
| 6015P | In distribution | |
| 0408 | In distribution | |
| 6015W | In distribution | |
| 0045 | In distribution | |
| 61617N | In distribution | |
| 0419-5 | In distribution | |
| 0211 | In distribution | |
| 0009-25 | In distribution | |
| 0011K25 | In distribution | |
| T9-5 | In distribution | |
| 0124-25 | In distribution | |
| 726-2213 | In distribution | |
| 0401-5 | Withdrawn | |
| 0127-25 | Withdrawn | |
| 0129 | Withdrawn | |
| 0414-5 | Withdrawn | |
| 0413-5 | Withdrawn | |
| 0014K25 | Withdrawn | |
| 0419-5 | Withdrawn | |
| 0020GB | Withdrawn | |
| 0417-5 | Withdrawn | |
| 0108-25 | Withdrawn | |
| 0129-25 | Withdrawn | |
| 0124-25 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Zirlux | Henry Schein, Inc. | 69 |
| remanium® | Dentaurum GmbH & Co. KG | 56 |
| Magnum Splendidum | Mesa DI Sala Giacomo & C. SNC | 47 |
| Ceramill Sintron® | Amann Girrbach AG | 47 |
| Magnum Solare | Mesa DI Sala Giacomo & C. SNC | 37 |
| Base metal alloy | Institut Straumann AG | 34 |
| Luminesse Ti-Cam Discs | Talladium, Inc. | 33 |
| Starbond CoS | S & S Scheftner GmbH | 24 |
| Dentorium | Wright Medical Technology, Inc. | 23 |
| Starbond Easy | S & S Scheftner GmbH | 22 |
| Magnum Hyperone | Mesa DI Sala Giacomo & C. SNC | 21 |
| Starbond Ti4 | S & S Scheftner GmbH | 19 |
Showing 12 of 627. All products under Alloy, Metal, Base
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K953594 | 1995-09-05 |
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.