TEETH, DENTURE, PLASTIC
FDA 510(k) clearance K792245 · decided 1980-01-04
Clearance details
- K-number
- K792245
- Device name
- TEETH, DENTURE, PLASTIC
- Applicant
- Dentsply Intl.
- Decision
- Substantially Equivalent
- Date received
- 1979-11-07
- Decision date
- 1980-01-04
- Days to decision
- 58 days
- Clearance type
- Traditional
- Product code
- ELM
- Device class
- 2
- Regulation number
- 872.3590
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| SR VIVODENT S, SR ORTHOTYP S, SR ORTHOLINGUAL S (K132984) | Ivoclar Vivadent, Inc. | 2014-01-14 |
| DENTAVIT, MONARCH, ACROTONE, SENATOR, DENTORIUM (K122955) | Wright Health Group , Ltd. | 2013-03-01 |
| NEW STETIC ARTIFICIAL TEETH (K122925) | New Stetic | 2013-02-12 |
| PHYSIOSTAR NFC (K122852) | Candulor USA, Inc. | 2012-12-06 |
| VERACIA (K121749) | Shofu Dental Corporation | 2012-09-07 |
| MERZ DENTAL GMBH ARTEGRAL HD PREFORMED PLASTIC DENTURE TEETH (K120404) | Merz Dental GmbH | 2012-05-21 |
| SR PHONARES II (K120736) | Ivoclar Vivadent, AG | 2012-05-14 |
| VERACIA SA (K113426) | Shofu Dental Corporation | 2012-02-08 |
| BREDENT NOVO.LIGN A/ BREDENT NOVO.LIGN P (K101064) | Bredent GmbH & Co. KG | 2010-09-14 |
| KAIFENG/CRYSTAL, KAILI, KAIJING, KAIYUE, MAIST AND KAITONG/ROYAL SYNTHETIC POLYMER TEETH (K101029) | Huge Dental Material Co., Ltd. | 2010-08-16 |
| SR PHONARES NHC (K093331) | Ivoclar Vivadent, Inc. | 2010-01-28 |
| GEBDI TRIBOS 501 (K092231) | Gebdi Dental-Products GmbH | 2009-11-24 |
Recalls involving this device
No recalls on record reference this clearance.