The following data is part of a premarket notification filed by Filmtech, Inc. with the FDA for Dental Handpiece And Accessory.
| Device ID | K963664 |
| 510k Number | K963664 |
| Device Name: | DENTAL HANDPIECE AND ACCESSORY |
| Classification | Handpiece, Air-powered, Dental |
| Applicant | FILMTECH, INC. 581 MCDONALD AVE. Brooklyn, NY 11218 |
| Contact | Jacob Posner |
| Correspondent | Jacob Posner FILMTECH, INC. 581 MCDONALD AVE. Brooklyn, NY 11218 |
| Product Code | EFB |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-13 |
| Decision Date | 1996-10-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D764B13070110 | K963664 | 000 |
| D6620709785020 | K963664 | 000 |
| D764B10700080 | K963664 | 000 |
| D764B10700090 | K963664 | 000 |
| D764B10700171 | K963664 | 000 |
| D764B10700181 | K963664 | 000 |
| D764B11070100 | K963664 | 000 |
| D764B11070110 | K963664 | 000 |
| D764B12070100 | K963664 | 000 |
| D764B12070110 | K963664 | 000 |
| D764B12100300 | K963664 | 000 |
| D764B13070100 | K963664 | 000 |
| D6620709236150 | K963664 | 000 |