Visalys Restorative Primer
FDA 510(k) K191523 · Kettenbach GmbH & Co. KG
510(k) numberK191523
Submission
- Device name
- Visalys Restorative Primer
- Applicant
- Kettenbach GmbH & Co. KG
Eschenburg, DE - Received
- June 10, 2019
- Decision date
- October 9, 2019
- 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 |
|---|---|---|
| K262243 | Profisil FreeLBH · Traditional | 09/03/2026SE |
| K250267 | Visalys® Bulk Fill 1 x 4 g Syringe (15060); Visalys® Bulk Fill 15 x 0.25 g Caps (15062)…EBF · Traditional | 03/14/2025SE |
| K230333 | Profisil Fluoride Varnish Combi pack (14801), Profisil Fluoride Varnish Normal pack mint…LBH · Traditional | 07/24/2023SE |
| K191527 | Visalys CemCore, Visalys Cem Core Try In PasteEMA · Traditional | 11/08/2019SE |
| K191524 | Visalys Tooth PrimerKLE · Traditional | 09/29/2019SE |
| K143104 | Visalys Core, Visalys PL-Core, Visalys PL-Core-C, Visalys PL-Core-XEBF · Traditional | 03/25/2015SE |
| K122039 | Kingscross PL-C+B-10, Kingscross PL-C+B-12, Kingscross PL-C+B-08, Kingscross BEBG · Traditional | 12/27/2012SE |
| K113279 | Identium Heavy, Identium Medium, Identium Scan Heavy, Identium Scan Medium, Identium…ELW · Special | 11/14/2011SE |
| K092867 | Identium Heavy, Medium, Medium Soft, LightELW · Traditional | 10/01/2009SE |
| K083701 | Panasil Initial Contact and Panasil TrayELW · Special | 01/09/2009SE |
Questions and answers
When was Visalys Restorative Primer cleared by the FDA?
Visalys Restorative Primer (K191523) received a 510(k) decision of Substantially Equivalent on October 9, 2019, 121 days after the submission was received.
What is the product code of K191523?
The FDA product code is KLE – Agent, Tooth Bonding, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3200.