The following data is part of a premarket notification filed by Union Broach, Div. Moyco Industries, Inc. with the FDA for Cyber-fil Alkenoate Cement Multi-purpose Kit (23900/23905/23910/23915/23920).
Device ID | K962733 |
510k Number | K962733 |
Device Name: | CYBER-FIL ALKENOATE CEMENT MULTI-PURPOSE KIT (23900/23905/23910/23915/23920) |
Classification | Cement, Dental |
Applicant | UNION BROACH, DIV. MOYCO INDUSTRIES, INC. 589 DAVIES DR. York, PA 17402 |
Contact | Chris M Lehr |
Correspondent | Chris M Lehr UNION BROACH, DIV. MOYCO INDUSTRIES, INC. 589 DAVIES DR. York, PA 17402 |
Product Code | EMA |
CFR Regulation Number | 872.3275 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-07-15 |
Decision Date | 1996-10-11 |