The following data is part of a premarket notification filed by A And V Ent. with the FDA for Dental Root Canal Bacterialcidal Lubricant.
| Device ID | K921713 |
| 510k Number | K921713 |
| Device Name: | DENTAL ROOT CANAL BACTERIALCIDAL LUBRICANT |
| Classification | Cleanser, Root Canal |
| Applicant | A AND V ENT. 227 COLCHESTER AVE. Burlington, VT 05401 |
| Contact | Victor L Ratkus |
| Correspondent | Victor L Ratkus A AND V ENT. 227 COLCHESTER AVE. Burlington, VT 05401 |
| Product Code | KJJ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-07 |
| Decision Date | 1993-11-04 |