The following data is part of a premarket notification filed by A-dec, Inc. with the FDA for A-dec 334/335 Delivery System.
| Device ID | K082985 |
| 510k Number | K082985 |
| Device Name: | A-DEC 334/335 DELIVERY SYSTEM |
| Classification | Unit, Operative Dental |
| Applicant | A-DEC, INC. 2601 CRESTVIEW DR. Newberg, OR 97132 -9257 |
| Contact | Thomas H Louisell |
| Correspondent | Thomas H Louisell A-DEC, INC. 2601 CRESTVIEW DR. Newberg, OR 97132 -9257 |
| Product Code | EIA |
| CFR Regulation Number | 872.6640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-10-07 |
| Decision Date | 2008-12-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10194665000059 | K082985 | 000 |
| 10194665006877 | K082985 | 000 |
| 10194665006860 | K082985 | 000 |
| 10194665006853 | K082985 | 000 |
| 10194665006846 | K082985 | 000 |
| 10194665006839 | K082985 | 000 |
| 10194665006822 | K082985 | 000 |
| 10194665006815 | K082985 | 000 |
| 10194665006808 | K082985 | 000 |
| 10194665007027 | K082985 | 000 |
| 10194665007034 | K082985 | 000 |
| 10194665007041 | K082985 | 000 |
| 10194665000042 | K082985 | 000 |
| 10194665000400 | K082985 | 000 |
| 10194665000394 | K082985 | 000 |
| 10194665000387 | K082985 | 000 |
| 10194665000370 | K082985 | 000 |
| 10194665000363 | K082985 | 000 |
| 10194665000356 | K082985 | 000 |
| 10194665000349 | K082985 | 000 |
| 10194665006792 | K082985 | 000 |