Nobilium
Nobiltone HI-I LIQ 33.8OZ
14manufacturers in China registered for this device type
167catalogue numbers in this listing
5510(k) clearances naming this product code
6recalls on this code
Who Else Makes It
Concentrated in Guangdong (6), Zhejiang (2), Hebei (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Aidite (Qinhuangdao) Technology Co., Ltd. | Qinhuangdao | Hebei | Repacker / relabeller | 17 |
| Shandong Huge Dental Material Corporation | Rizhao | Shandong | Manufacturer | 17 |
| Shen FU Arts LAB | Shen Zhen | Guangdong | Manufacturer | 15 |
| Liaoning Upcera Co., Ltd. | Benxi | Liaoning | Contract manufacturer | 10 |
| Shenzhen Upcera Digital Dental Technology Co., Ltd. | Shenzhen | Guangdong | Exporter | 10 |
| Riton 3D Technology Co., Ltd. | Guangzhou | Guangdong | Repacker / relabeller | 9 |
| Yamahachi Dental Material (Changshu) Co., Ltd. | Changshu | Jiangsu | Manufacturer | 9 |
| Guangzhou Heygears Imc.inc | Guangzhou | Guangdong | Specification developer | 8 |
| Hangzhou SHINING3D Dental Technology Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 7 |
| Ningbo Sezen Technology Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 7 |
| Hunan Vsmile Biotechnology Co., Ltd. | Changsha | Hunan | Contract manufacturer | 6 |
| Shenzhen Piocreat 3D Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 6 |
Showing 12 of 14. All 14 manufacturers in China registered for Resin, Denture, Relining, Repairing, Rebasing
Record
| Listed by | Cmp Industries, LLC, United States |
|---|---|
| FDA product code | EBI |
| Device type | Resin, Denture, Relining, Repairing, Rebasing |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3760 |
| 510(k) | K033020 |
| Record published | 2016-11-17 |
| Record revised | 2021-11-10 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Distribution end date | 2016-11-17 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 8105 | In distribution | |
| 21200NC | In distribution | |
| I8133 | In distribution | |
| 8132 | In distribution | |
| 24000P9NC | In distribution | |
| 8162 | In distribution | |
| 21104N | In distribution | |
| 21103SL | In distribution | |
| 81122 | In distribution | |
| 8175N | In distribution | |
| 3749 | In distribution | |
| 3311GB | In distribution | |
| 7462 | In distribution | |
| 21143SL | In distribution | |
| 21113B | In distribution | |
| 21200 | In distribution | |
| 8114 | In distribution | |
| 21103B | In distribution | |
| 8134 | In distribution | |
| 21103T | In distribution | |
| 8116 | In distribution | |
| 81103 | In distribution | |
| 21142T | In distribution | |
| 21104 | In distribution | |
| I8136 | In distribution | |
| 21143NC | In distribution | |
| 21204 | In distribution | |
| 81102 | In distribution | |
| 3746 | In distribution | |
| 8172 | In distribution | |
| 3314GB | In distribution | |
| I8131 | In distribution | |
| 21122T | In distribution | |
| 8103-1K | In distribution | |
| 8142 | In distribution | |
| 8135N | In distribution | |
| 21154SL | In distribution | |
| 21152 | In distribution | |
| 7470 | In distribution | |
| 8174 | In distribution | |
| 3312 | In distribution | |
| 21103 | In distribution | |
| I8132 | In distribution | |
| 21203 | In distribution | |
| 21122 | In distribution | |
| 21202NC | In distribution | |
| 21112FX | In distribution | |
| 21102FX | In distribution | |
| 8143 | In distribution | |
| 7467 | In distribution | |
| 8115 | In distribution | |
| 21122FX | In distribution | |
| 8131N | In distribution | |
| 21113NC | In distribution | |
| 8106 | In distribution | |
| 21103BK | In distribution | |
| 7452 | In distribution | |
| 8132N | In distribution | |
| 3305 | In distribution | |
| 8122 | In distribution | |
| 21202 | In distribution | |
| 3307-1K | In distribution | |
| 3317 | In distribution | |
| 904757VS | In distribution | |
| 8173 | In distribution | |
| 3301 | In distribution | |
| 21123A | In distribution | |
| 21102 | In distribution | |
| 8171 | In distribution | |
| 21103A | In distribution | |
| 8101 | In distribution | |
| 3748 | In distribution | |
| 8176N | In distribution | |
| I8135 | In distribution | |
| 21154FX | In distribution | |
| 8173N | In distribution | |
| 8161 | In distribution | |
| 3313 | In distribution | |
| 21103FX | In distribution | |
| 8123 | In distribution | |
| 8131 | In distribution | |
| 3311 | In distribution | |
| 21104FX | In distribution | |
| 21203T | In distribution | |
| 8172N | In distribution | |
| 81101 | In distribution | |
| 21123 | In distribution | |
| 8176 | In distribution | |
| 7471 | In distribution | |
| 81123 | In distribution | |
| 8176T | In distribution | |
| I8115 | In distribution | |
| 21153B | In distribution | |
| 21153 | In distribution | |
| 8174N | In distribution | |
| 21105 | In distribution | |
| 8171T50K | In distribution | |
| 21143FX | In distribution | |
| 3747GB | In distribution | |
| 8171N | In distribution | |
| I8114 | In distribution | |
| 21201NC | In distribution | |
| 21204NC | In distribution | |
| 21102T | In distribution | |
| I8192 | In distribution | |
| 8104 | In distribution | |
| 8175 | In distribution | |
| 21123SL | In distribution | |
| 8133 | In distribution | |
| 21153BK | In distribution | |
| 8136 | In distribution | |
| 21113BK | In distribution | |
| 3306 | In distribution | |
| 7461 | In distribution | |
| 21204T | In distribution | |
| 8163 | In distribution | |
| 8175T | In distribution | |
| 21103NC | In distribution | |
| 21113SL | In distribution | |
| 21152FX | In distribution | |
| 21143 | In distribution | |
| 3748GB | In distribution | |
| I8191 | In distribution | |
| 81103BK | In distribution | |
| 8103 | In distribution | |
| 21203NC | In distribution | |
| 8121 | In distribution | |
| 3749GB | In distribution | |
| 8141 | In distribution | |
| 21154 | In distribution | |
| 3319 | In distribution | |
| 21123BK | In distribution | |
| 8133N | In distribution | |
| 24000P9 | In distribution | |
| 21101NC | In distribution | |
| 8191 | In distribution | |
| 8136N | In distribution | |
| 21113 | In distribution | |
| 7452-25 | In distribution | |
| 21153FX | In distribution | |
| 7465 | In distribution | |
| 21113FX | In distribution | |
| 8134N | In distribution | |
| 21142 | In distribution | |
| 21123B | In distribution | |
| 81123BK | In distribution | |
| 21142FX | In distribution | |
| 21123TBK | In distribution | |
| 21112 | In distribution | |
| 21153SL | In distribution | |
| 3314 | In distribution | |
| 7450 | In distribution | |
| 3307 | In distribution | |
| I8116 | In distribution | |
| I8134 | In distribution | |
| 3747 | In distribution | |
| 21103BKNC | In distribution | |
| 3410 | In distribution | |
| 8192 | In distribution | |
| 21201 | In distribution | |
| 21123FX | In distribution | |
| 21113A | In distribution | |
| 21123NC | In distribution | |
| 8102 | In distribution | |
| 8135 | In distribution | |
| 8193 | Withdrawn | |
| I8134 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Vertex-Dental BV | Vertex-Dental B.V. | 760 |
| HI-I® | Fricke International, Inc. | 490 |
| Vitacrilic® | Fricke International, Inc. | 249 |
| Nature-Cryl® | GC America Inc. | 205 |
| Hygenic | Coltene/Whaledent Gmbh & Co. KG | 152 |
| AvaDent | Global Dental Science | 150 |
| Dentorium | Wright Medical Technology, Inc. | 137 |
| Duracetal | The Myerson Company Limited | 136 |
| RE-Fine Bright | Yamahachi Dental MFG. Co. | 134 |
| Axcent Acrylics | Garreco, LLC | 132 |
| Unbreakable by TCS | Thermoplastic Comfort SYS | 96 |
| Karadent by TCS | Thermoplastic Comfort SYS | 91 |
Showing 12 of 3,288. All products under Resin, Denture, Relining, Repairing, Rebasing
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K170375 | 2017-10-02 |
| K072851 | 2008-02-20 |
| K072402 | 2007-10-19 |
| K033020 | 2003-12-19 |
| K902972 | 1990-10-04 |
Recalls Naming This Product
4 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Cmp Industries, LLC | 510(k) number | 2016-04-28 | Class II | Material/Component Contamination | Possible presence of foreign material (rust). | 77 units Total | 2018-05-25 |
| Cmp Industries, LLC | 510(k) number | 2016-04-28 | Class II | Material/Component Contamination | Possible presence of foreign material (rust). | 77 units Total | 2018-05-25 |
| Cmp Industries, LLC | 510(k) number | 2016-03-02 | Class II | Material/Component Contamination | Possible presence of foreign material (rust). | 236 pieces (25 pieces/11 oz, 211 pieces/1 Quart) | 2017-03-16 |
| Cmp Industries, LLC | 510(k) number | 2013-11-18 | Class II | Nonconforming Material/Component | During the current inspection of CMP Industries, the FDA Investigator discovered that the firm had conducted a recall of Impak Acrylic Liquid Batch 103113 in 2013 due to potential rust without notifying the district. | 246 units | 2018-05-23 |
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2018-09-12 | Class II | Material/Component Contamination | Foreign material in product | 400 units | 2020-05-19 |
| 2018-09-12 | Class II | Material/Component Contamination | Foreign material in product | 40 units | 2020-05-19 |
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.