The following data is part of a premarket notification filed by Dentsply Intl. with the FDA for Teeth, Denture, Plastic.
| Device ID | K792245 |
| 510k Number | K792245 |
| Device Name: | TEETH, DENTURE, PLASTIC |
| Classification | Denture, Plastic, Teeth |
| Applicant | DENTSPLY INTL. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | ELM |
| CFR Regulation Number | 872.3590 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-11-07 |
| Decision Date | 1980-01-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06970553800102 | K792245 | 000 |
| 06970553800024 | K792245 | 000 |
| 06970553800031 | K792245 | 000 |
| 06970553800034 | K792245 | 000 |
| 06970553800058 | K792245 | 000 |
| 06970553800065 | K792245 | 000 |
| 06970553800072 | K792245 | 000 |
| 06970553800089 | K792245 | 000 |
| 06970553800093 | K792245 | 000 |
| 06970553800096 | K792245 | 000 |
| 06970553800017 | K792245 | 000 |