The following data is part of a premarket notification filed by Den-tal-ez Mfg Co., Inc. with the FDA for As3000 Operative Dental Unit (delivery System).
| Device ID | K931204 |
| 510k Number | K931204 |
| Device Name: | AS3000 OPERATIVE DENTAL UNIT (DELIVERY SYSTEM) |
| Classification | Unit, Operative Dental |
| Applicant | DEN-TAL-EZ MFG CO., INC. 1816 COLONIAL VILLAGE LN. Lancaster, PA 17601 |
| Contact | William Lambertson |
| Correspondent | William Lambertson DEN-TAL-EZ MFG CO., INC. 1816 COLONIAL VILLAGE LN. Lancaster, PA 17601 |
| Product Code | EIA |
| CFR Regulation Number | 872.6640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-03-09 |
| Decision Date | 1993-07-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D06036553580 | K931204 | 000 |
| D06036553570 | K931204 | 000 |
| D0603655314G0 | K931204 | 000 |
| D0603655313G0 | K931204 | 000 |