Agent, Tooth Bonding, Resin
Regulation 872.3200
9510(k)s in 12 months (421 all time)
0recalls in 12 months (20 all time)
20recalls that name a 510(k)
Top companies in KLE
| Company | 510(k)s | Recalls |
|---|---|---|
| Ultradent Products, Inc. | 19 | 2 |
| Dentsply Intl. | 20 | 0 |
| Heraeus Kulzer, Inc. | 19 | 0 |
| Bisco, Inc. | 18 | 0 |
| Parkell | 16 | 0 |
| Kerr Corporation | 4 | 10 |
| Kuraray Medical, Inc. | 14 | 0 |
| Shofu Dental Corp. | 13 | 0 |
| GC America, Inc. | 11 | 0 |
| Pulpdent Corp. | 11 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 2, 2025 | 3M Unitek Corporation 3M Unitek Transbond Plus Self-Etching Primer REF
712-090 (100 unit box)
712-091 (20 unit box)
Transbond Plus Self Etching Primer is an orthodontic all-in-one etchant and primer that is used in the bo Open, Classified |
KLE | K992048 |
| Jun 1, 2022 | Ultradent Products, Inc. Peak Universal Bond Self-Etch Bottle Kit, Part: 4541; Peak Universal Bond Self-Etch Intro Kit, Part: 4554; Peak SE Primer 4pk Refill, Part: 5135; Peak Universal Bond Sample SE, Part: S4554. For use i Completed |
KLE | K063558 |
| Sep 28, 2017 | Cosmedent, Inc. Cosmedent's Etching Gel, 3g, 37% Phosphoric Acid, Rx only. Packaged in 3g Luer Lock syringes.
Used for etching enamel and dentin. Terminated |
KLE | K052501 |
| Jan 6, 2017 | Voco GmbH VOCO Futurabond M+ adhesive, RF 1515, Manufactured by VOCO GmbH, Futurabond M+ is a dental adhesive for use with methacrylate-based restorative, core build-up or luting materials. It can be applied wi Terminated |
KLE | K141610 |
| Jul 29, 2014 | Novocol, Inc. Darby Dental Supply Compolite Bond SE Self-Etch/Light-Curing. This product is used to adhere restorative material to the tooth during restorations. Package contains 100 0.125 mL unit dose tips, 100 Terminated |
KLE | K042614 |
| Jul 29, 2014 | Novocol, Inc. Henry Schein Natural Elegance SE Bond Self-Etch Light-Cure
Adhesive contains 50 0.125 mL unit dose tips, 50 applicator brushes, and a product insert. Terminated |
KLE | K042614 |
| Jun 18, 2012 | Ultradent Products, Inc. Peak SE Primer Kits (4 syringes per kit) manufactured by Ultradent Products, Inc, South Jordan, UT, Self Etch Primer. The product is contained within prefilled, labeled syringes in a transparent plas Terminated |
KLE | K063558 |
| Mar 2, 2012 | Kerr Corporation Brand name: Bond-1 Primer/Adhesive, a resin tooth bonding
agent.
Item # Item Description
N01I Bond-1 Prim/Adhesive Kit
N01IAA Bond-1 Terminated |
KLE | K973388 |
| Mar 16, 2010 | Sybron Dental Specialties Bond-1 Primer/Adhesive.
The intended use of this device is adhesion to dentin of various polymeric filling materials (composites) used with other conditioners or combination of conditioners for bondi Terminated |
KLE | K973388 |
| Oct 2, 2007 | Heraeus Kulzer Inc., Dental Products Division Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, Assortment Value Pack 3 x 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No Terminated |
KLE | K992292 |
| Oct 2, 2007 | Heraeus Kulzer Inc., Dental Products Division Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, contents: 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66001710. Terminated |
KLE | K992292 |
| Sep 23, 2006 | Kerr Corp OptiBond Solo Plus Self-Etch Adhesive System, Part Number 31966 Terminated |
KLE | K014027 K991808 |
| Mar 28, 2006 | Kerr Corp Tooth bonding resin. Premise Starter Unidose Kit, Part Number 32684, Lot Numbers 427915 Terminated |
KLE | K991808 |
| Mar 28, 2006 | Kerr Corp Tooth bonding resin. Premise Master Unidose Kit, Part Number 32612, Lot Numbers 428576 Terminated |
KLE | K991808 |
| Mar 28, 2006 | Kerr Corp Tooth bonding resin. Premise Master Syringe Kit, Part Number 32611, Lot Numbers 428730 Terminated |
KLE | K991808 |
| Mar 28, 2006 | Kerr Corp Tooth bonding resin. Nexus 2 Starter Kit, Part Number 31955, Lot Numbers 428570 & 429640 Terminated |
KLE | K991808 |
| Mar 28, 2006 | Kerr Corp Tooth bonding resin. Nexus 2 Kit, Part Number 31954, Lot Number 428572 Terminated |
KLE | K991808 |
| Mar 28, 2006 | Kerr Corp Tooth bonding resin. Optibond Solo Plus Dual Cure Kit, Part Number 31736, Lot Number 427793 Terminated |
KLE | K991808 |
| Mar 28, 2006 | Kerr Corp Tooth bonding resin. Optibond Solo Plus Bottle Kit, Part Number 31514, Lot Number 429106 Terminated |
KLE | K991808 |
| Mar 28, 2006 | Kerr Corp Tooth bonding resin. Optibond Solo Plus, Part Number 31513, Lot Numbers 427936, 428569, & 428290 Terminated |
KLE | K991808 |
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