The following data is part of a premarket notification filed by A-dec, Inc. with the FDA for A-dec 300, A-dec 500.
| Device ID | K213932 |
| 510k Number | K213932 |
| Device Name: | A-dec 300, A-dec 500 |
| Classification | Unit, Operative Dental |
| Applicant | A-dec, Inc. 2601 Crestview Drive Newberg, OR 97132 |
| Contact | Raquel Peregrino De Brito |
| Correspondent | Raquel Peregrino De Brito A-dec, Inc. 2601 Crestview Drive Newberg, OR 97132 |
| Product Code | EIA |
| CFR Regulation Number | 872.6640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-16 |
| Decision Date | 2022-03-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10194665005320 | K213932 | 000 |
| 10194665005399 | K213932 | 000 |
| 10194665005405 | K213932 | 000 |
| 10194665005412 | K213932 | 000 |
| 10194665005429 | K213932 | 000 |
| 10194665005436 | K213932 | 000 |
| 10194665005856 | K213932 | 000 |
| 10194665005863 | K213932 | 000 |
| 10194665005870 | K213932 | 000 |
| 10194665005894 | K213932 | 000 |
| 10194665005900 | K213932 | 000 |
| 10194665005917 | K213932 | 000 |
| 10194665005986 | K213932 | 000 |
| 10194665005993 | K213932 | 000 |
| 10194665006730 | K213932 | 000 |