Msn-006
510(k) K141562
Msn-006 is a Class II device made by Gc America Inc., cleared under FDA 510(k) K141562 on 5 Sep 2014, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK141562 | Date5 Sep 2014 | StatusActive |
Official records
- FDA 510(k) database K141562
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- EBG
- FDA applicant
- GC America, Inc.
- Device class
- Class II
- Regulation
- 21 CFR Part 872.3770
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K141562
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| TEMPSMART™ 009392 | 009392 / 009392 | 14548161316828 | Total Volume 48 mL | On the market |
| TEMPSMART™ 009392 | 009392 / 009392 | D0470093921 | Total Volume 48 mL | On the market |
| TEMPSMART™ 009393 | 009393 / 009393 | D0470093931 | Total Volume 48 mL | On the market |
| TEMPSMART™ 009393 | 009393 / 009393 | 14548161316842 | Total Volume 48 mL | On the market |
| TEMPSMART™ 009394 | 009394 / 009394 | 14548161316859 | Total Volume 48 mL | On the market |
| TEMPSMART™ 009394 | 009394 / 009394 | D0470093941 | Total Volume 48 mL | On the market |
| TEMPSMART™ 009395 | 009395 / 009395 | 14548161316866 | Total Volume 48 mL | On the market |
| TEMPSMART™ 009395 | 009395 / 009395 | D0470093951 | Total Volume 48 mL | On the market |
| TEMPSMART™ 009396 | 009396 / 009396 | 14548161316873 | Total Volume 48 mL | On the market |
| TEMPSMART™ 009396 | 009396 / 009396 | D0470093961 | Total Volume 48 mL | On the market |
| TEMPSMART™ 009397 | 009397 / 009397 | D0470093971 | Total Volume 48 mL | On the market |
| TEMPSMART™ 009397 | 009397 / 009397 | 14548161316880 | Total Volume 48 mL | On the market |
| TEMPSMART™ 009398 | 009398 / 009398 | 14548161316897 | Total Volume 10 mL | On the market |
| TEMPSMART™ 009398 | 009398 / 009398 | D0470093981 | Total Volume 10 mL | On the market |
| TEMPSMART™ 009399 | 009399 / 009399 | 14548161316903 | Total Volume 10 mL | On the market |
| TEMPSMART™ 009399 | 009399 / 009399 | D0470093991 | Total Volume 10 mL | On the market |
| TEMPSMART™ 009400 | 009400 / 009400 | 14548161316910 | Total Volume 10 mL | On the market |
| TEMPSMART™ 009400 | 009400 / 009400 | D0470094001 | Total Volume 10 mL | On the market |
| TEMPSMART™ 009401 | 009401 / 009401 | 14548161316927 | Total Volume 10 mL | On the market |
| TEMPSMART™ 009401 | 009401 / 009401 | D0470094011 | Total Volume 10 mL | On the market |
| TEMPSMART™ 420000 | 420000 / 420000 | 10386040012492 | On the market | |
| TEMPSMART™ 420000 | 420000 / 420000 | D6584200001 | On the market |
Similar devices
Other devices filed under FDA product code EBG (Crown And Bridge, Temporary, Resin).
- G-CAM GC00251 by GRAPHENANO DENTAL SL.
- ANAXDENT PMMA U Monolayer BLANK B1 98,5/20mm 18920020 by UNION DENTAL SA
- SMARTEMP by PARKELL, INC.
- INTERIM TEMP. CROWN & BRIDGE RESIN by Coe Laboratories, Inc.
- G-CAM GC00040 by GRAPHENANO DENTAL SL.
- ANAXDENT PMMA U MULTIBLANK A2 98,5/16mm 18121216 by UNION DENTAL SA
- TEMPFLEX by KERR CORPORATION
- PEKKTON IVORY by Cendres & Metaux SA
- TERA HARZ II BR-23D2-1000 NONE by Graphy Inc.
- C&B 5.0 Hybrid by ARUM DENTISTRY Co., Ltd.