Xeno III Dental Adhesive
FDA 510(k) K023776 · Dentsply Intl.
510(k) numberK023776
Submission
- Device name
- Xeno III Dental Adhesive
- Applicant
- Dentsply Intl.
York, PA, US - Received
- November 12, 2002
- Decision date
- January 23, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code KLE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260485 | Any-EtchKLE · Traditional | Mediclus Co., Ltd. | 05/14/2026SE |
| K260430 | Porcelain Etch GelKLE · Traditional | Belport Company, Inc., Gingi-Pak | 04/10/2026SE |
| 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 |
|---|---|---|
| K140347 | Ankylos C/X Implant SystemDZE · Traditional | 08/20/2014SE |
| K130862 | Cavitron Prophy-Jet Air Polishing Prophylaxis SystemELC · Traditional | 07/23/2013SE |
| K123615 | Iris - High Strength Glass CeramicEIH · Traditional | 02/22/2013SE |
| K103244 | Qmix 2IN1 Endodontic Irrigating SolutionKJJ · Traditional | 02/14/2011SE |
| K093221 | Pre-Cemented Orthodontic Bracket System Extension IIDYH · Special | 10/30/2009SE |
| K083805 | Ankylos C/X Dental Implant SystemDZE · Traditional | 05/22/2009SE |
| K082198 | Durashield PlusLBH · Traditional | 10/29/2008SE |
| K072730 | Friadent Cercon and Ankylos Cercon Balance AbutmentsNHA · Traditional | 03/27/2008SE |
| K072989 | Axis SystemEFB · Traditional | 01/28/2008SE |
| K073117 | Dentin Desensitizer AgentLBH · Traditional | 12/19/2007SE |
Questions and answers
When was Xeno III Dental Adhesive cleared by the FDA?
Xeno III Dental Adhesive (K023776) received a 510(k) decision of Substantially Equivalent on January 23, 2003, 72 days after the submission was received.
What is the product code of K023776?
The FDA product code is KLE – Agent, Tooth Bonding, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3200.