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 |