American Dental Products Se Bondeasy
FDA 510(k) K093014 · American Dental Products, Inc.
510(k) numberK093014
Submission
- Device name
- American Dental Products Se Bondeasy
- Applicant
- American Dental Products, Inc.
Bensenville, IL, US - Received
- September 29, 2009
- Decision date
- April 16, 2010
- 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 |
|---|---|---|
| K994368 | American Dental Products Caries-Detector PlusLFC · Traditional | 03/14/2000SE |
| K991099 | American Dental Products Etch-DetectEBC · Traditional | 06/10/1999SE |
| K973185 | American Dental Products HB-35 Desensitizer with FluorideKLE · Traditional | 11/14/1997SE |
| K964133 | American Dental Products HG 35 Desensitizer with FluorideKLE · Traditional | 01/09/1997SE |
| K954637 | American Dental Products Tissue Conditioner & Temporary RelinerEBI · Traditional | 12/28/1995SE |
| K954876 | American Dental Products Root Canal Sealer, Wach's FormulaEMA · Traditional | 11/15/1995SE |
| K954701 | American Dental Products Pit & Fissue Sealant Light CuringEBC · Traditional | 10/30/1995SE |
| K954408 | American Dental Products Light Activated Composite Resin Core Buildup Blue PasteeEBF · Traditional | 10/30/1995SE |
| K954407 | American Dental Products White Composite Resin Core Paste with FluorideEBF · Traditional | 10/30/1995SE |
| K954406 | American Dental Products Composite Resin Core Paste with FluorideEBF · Traditional | 10/30/1995SE |
Questions and answers
When was American Dental Products Se Bondeasy cleared by the FDA?
American Dental Products Se Bondeasy (K093014) received a 510(k) decision of Substantially Equivalent on April 16, 2010, 199 days after the submission was received.
What is the product code of K093014?
The FDA product code is KLE – Agent, Tooth Bonding, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3200.