The following data is part of a premarket notification filed by Worldwide Dental, Inc. with the FDA for Instrument,filling,plastic,dental.
| Device ID | K945077 |
| 510k Number | K945077 |
| Device Name: | INSTRUMENT,FILLING,PLASTIC,DENTAL |
| Classification | Burnisher, Operative |
| Applicant | WORLDWIDE DENTAL, INC. 12890 AUTOMOBILE BLVD., SUITE A Clearwater, FL 34622 -4733 |
| Contact | William M Domin |
| Correspondent | William M Domin WORLDWIDE DENTAL, INC. 12890 AUTOMOBILE BLVD., SUITE A Clearwater, FL 34622 -4733 |
| Product Code | EKJ |
| CFR Regulation Number | 872.4565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-17 |
| Decision Date | 1994-11-30 |