Adhesive 1
FDA 510(k) K050331 · Southern Dental Industries, Inc.
510(k) numberK050331
Submission
- Device name
- Adhesive 1
- Applicant
- Southern Dental Industries, Inc.
Bensenville, IL, US - Received
- February 10, 2005
- Decision date
- March 24, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| 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 |
|---|---|---|
| K062065 | Riva Luting PlusEMA · Traditional | 11/15/2006SE |
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| K051008 | SetEMA · Traditional | 06/15/2005SE |
| K050871 | Riva ProtectEBC · Traditional | 06/10/2005SE |
| K050870 | Riva Light CureEMA · Traditional | 06/03/2005SE |
| K042452 | Riva SilverEMA · Traditional | 12/07/2004SE |
| K040393 | Riva LutingEMA · Traditional | 04/30/2004SE |
| K032152 | Benco AdmixEJJ · Traditional | 08/06/2003SE |
| K031658 | Benco SphericalEJJ · Traditional | 07/29/2003SE |
| K030568 | RadiiEBZ · Traditional | 04/24/2003SE |
Questions and answers
When was Adhesive 1 cleared by the FDA?
Adhesive 1 (K050331) received a 510(k) decision of Substantially Equivalent on March 24, 2005, 42 days after the submission was received.
What is the product code of K050331?
The FDA product code is KLE – Agent, Tooth Bonding, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3200.