The following data is part of a premarket notification filed by Medidenta Intl., Inc. with the FDA for Twist Reciprocating Disposable Prophy Angle.
| Device ID | K973062 |
| 510k Number | K973062 |
| Device Name: | TWIST RECIPROCATING DISPOSABLE PROPHY ANGLE |
| Classification | Handpiece, Belt And/or Gear Driven, Dental |
| Applicant | MEDIDENTA INTL., INC. 39-23 62ND ST. Woodside, NY 11377 |
| Contact | Robert T Postal |
| Correspondent | Robert T Postal MEDIDENTA INTL., INC. 39-23 62ND ST. Woodside, NY 11377 |
| Product Code | EFA |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-08-18 |
| Decision Date | 1997-10-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50732224003363 | K973062 | 000 |
| 00732224000077 | K973062 | 000 |
| 00732224000084 | K973062 | 000 |
| 50732224000362 | K973062 | 000 |
| 50732224000379 | K973062 | 000 |
| 50732224002915 | K973062 | 000 |
| 50732224002922 | K973062 | 000 |
| 50732224002939 | K973062 | 000 |
| 50732224002946 | K973062 | 000 |
| 50732224002953 | K973062 | 000 |
| 50732224003332 | K973062 | 000 |
| 50732224003349 | K973062 | 000 |
| 50732224003356 | K973062 | 000 |
| 00732224000060 | K973062 | 000 |