The following data is part of a premarket notification filed by Preventive Technologies, Inc. with the FDA for Disposable Prophylaxis Angle.
| Device ID | K951016 |
| 510k Number | K951016 |
| Device Name: | DISPOSABLE PROPHYLAXIS ANGLE |
| Classification | Cup, Prophylaxis |
| Applicant | PREVENTIVE TECHNOLOGIES, INC. 1201 WOOD RIDGE CENTER DR. SUITE 112 Charlotte, NC 28217 -1988 |
| Contact | Al K Ing |
| Correspondent | Al K Ing PREVENTIVE TECHNOLOGIES, INC. 1201 WOOD RIDGE CENTER DR. SUITE 112 Charlotte, NC 28217 -1988 |
| Product Code | EHK |
| CFR Regulation Number | 872.6290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-06 |
| Decision Date | 1995-05-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D02411444433 | K951016 | 000 |
| D02411000233 | K951016 | 000 |
| D02411000333 | K951016 | 000 |
| D02411000433 | K951016 | 000 |
| D02411000533 | K951016 | 000 |
| D02411222433 | K951016 | 000 |
| D02411222533 | K951016 | 000 |
| D02411333433 | K951016 | 000 |
| D02411333533 | K951016 | 000 |
| D02411000133 | K951016 | 000 |