Optibond
FDA 510(k) K923546 · Kerr Corporation (Danbury)
510(k) numberK923546
Submission
- Device name
- Optibond
- Applicant
- Kerr Corporation (Danbury)
Romulus, MI, US - Received
- July 16, 1992
- Decision date
- September 29, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K252450 | Adhese 2KLE · Traditional | Ivoclar Vivadent, Inc. | 03/05/2026SE |
| K260682 | Bond-PR Universal AdhesiveKLE · Traditional | Premier Dental Products Company | 03/03/2026SE |
| K251587 | VITA VMLC PrimerKLE · Traditional | Vita Zahnfabrik H. Rauter GmbH & Co. Kg. | 02/23/2026SE |
| K252151 | els unibondKLE · Traditional | Saremco Dental AG | 12/05/2025SE |
| K252469 | Magnabond Se; Magnabond Universal; Magnabond Universal DcaKLE · Traditional | Dmp Dental Industry S.A. | 11/06/2025SE |
| K251124 | G-Bond UniversalKLE · Traditional | GC America, Inc. | 10/02/2025SE |
| K242530 | HF-Etchant Hydrofluoric Acid Etching GelKLE · Traditional | Rizhao Huge Biomaterials Company, Ltd. | 12/20/2024SE |
| K242749 | TopCEM Ceramic Primer Ceramic Coupling AgentKLE · Traditional | Rizhao Huge Biomaterials Company, Ltd. | 11/08/2024SE |
More from Rizhao Huge Biomaterials Company, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K051545 | L.E. Demetron IIEBZ · Traditional | 07/18/2005SE |
| K020091 | Optilux 501EBZ · Traditional | 03/21/2002SE |
| K951663 | Tytin REJJ · Traditional | 06/06/1995SE |
| K951511 | Tytin AdmixEJJ · Traditional | 05/02/1995SE |
| K942480 | M4 Contra-Angle HandpieceEGS · Traditional | 01/27/1995SE |
| K940513 | OptibondKLE · Traditional | 04/15/1994SE |
| K935535 | TytinEJJ · Traditional | 03/11/1994SE |
| K934690 | Kerr Optibond, ModificationKLE · Traditional | 12/30/1993SE |
| K915847 | Automix Dental AmalgamatorEFD · Traditional | 03/02/1992SE |
| K904756 | MatricsESD · Traditional | 03/15/1991SE |
Questions and answers
When was Optibond cleared by the FDA?
Optibond (K923546) received a 510(k) decision of Substantially Equivalent on September 29, 1992, 75 days after the submission was received.
What is the product code of K923546?
The FDA product code is KLE – Agent, Tooth Bonding, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3200.