Varnish, Cavity
Regulation 872.3260
6510(k)s in 12 months (139 all time)
0recalls in 12 months (9 all time)
6recalls that name a 510(k)
Top companies in LBH
| Company | 510(k)s | Recalls |
|---|---|---|
| Pulpdent Corp. | 10 | 0 |
| Ultradent Products, Inc. | 9 | 1 |
| Scientific Pharmaceuticals | 9 | 0 |
| Dentsply Intl. | 6 | 0 |
| Novamin Technology, Inc. | 6 | 0 |
| Centrix, Inc. | 5 | 0 |
| Ivoclar Vivadent, AG | 4 | 0 |
| CAO Group, Inc. | 3 | 0 |
| Dental Dimensions Supply Co. | 3 | 0 |
| Voco GmbH | 3 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 12, 2023 | Keystone Industries Keystone Bosworth Copaliner Cavity Varnish .5oz (14 ml)- Intended to provide a marginal seal between the dentin and amalgam which helps to protect against penetration of amalgam into the dentina
Item Open, Classified |
LBH | K933505 |
| Jun 8, 2023 | Young Dental Manufacturing I, LLC BencoDental iris 5% NaF varnish, WHITE MINT ITEM # 4323-635; cavity varnish Open, Classified |
LBH | K153334 |
| Oct 30, 2019 | Young Dental Manufacturing Co, LLC Oral-B, Practitioner Series, 5% Sodium Fluoride Varnish, 500 units (40mL/each) - Product Usage: For dentinal hypersensitivity and for the reduction of post-operative sensitivity. Open, Classified |
LBH | K153334 |
| Jul 12, 2018 | Ultradent Products, Inc. Enamelast Cool Mint/OT Varnish 5% NaF Mint
Label Enamelast Unit Dose 200pk Cool Mint:
Enamelast 5% Sodium Fluoride
Unit Dose 200pk Kit - Cool Mint REF/UP 4352
Rx
CONTENTS:
200 x 0.4 ml Unit Dose
Terminated |
LBH | K132109 |
| Jul 6, 2018 | 3M Company - Health Care Business 3M Fast Release Varnish, 5% Sodium Fluoride, Mint Flavor, Rx Only, single use. 200 pack, with each package containing 1 0.40 ml varnish and 1 applicator brush.
Product is applied to tooth surfaces Terminated |
LBH | K132109 |
| Dec 1, 2014 | Dharma Research, Inc. Dharma Cavity Varnish 15mL Terminated |
LBH | None listed |
| Dec 1, 2014 | Dharma Research, Inc. Dharma Cavity Varnish with Fluoride Terminated |
LBH | None listed |
| Nov 24, 2014 | Discus Dental LLC Relief ACP Oral Care Gel intended to relieve discomfort from dentin sensitivity. Sold separately in single, single syringe, 4 packs, 6 packs and in teeth whitening kits Terminated |
LBH | K062176 |
| May 23, 2014 | Heraeus Kulzer, LLC. Gluma Desensitizer Power Gel
Product Usage: Usage:
This is a class 2 medical device. For reduction or elimination of pain in exposed cervical areas that do not require restoration. It is also used f Terminated |
LBH | None listed |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.