Enamel Etching Gel
FDA 510(k) K910803 · Gresco Products, Inc.
510(k) numberK910803
Submission
- Device name
- Enamel Etching Gel
- Applicant
- Gresco Products, Inc.
Stafford, TX, US - Received
- February 26, 1991
- Decision date
- March 15, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| K261129 | OrthoFitDYH · Traditional | Spident Co., Ltd. | 07/02/2026SE |
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More from Dentscare Ltda
| 510(k) | Device | Decision |
|---|---|---|
| K981524 | PrilaneEIH · Traditional | 07/10/1998SE |
| K913405 | Kar-D-TekLFC · Traditional | 10/28/1991SE |
| K910813 | Met-EtchEBC · Traditional | 05/07/1991SE |
| K901973 | CP-3 Dental Polishing MaterialEJR · Traditional | 06/01/1990SE |
| K854495 | Gresco N.P. Dental AlloyEJH · Traditional | 12/27/1985SE |
| K854494 | Ceram-EtchEBC · Traditional | 12/23/1985SE |
Questions and answers
When was Enamel Etching Gel cleared by the FDA?
Enamel Etching Gel (K910803) received a 510(k) decision of Substantially Equivalent on March 15, 1991, 17 days after the submission was received.
What is the product code of K910803?
The FDA product code is DYH – Adhesive, Bracket And Tooth Conditioner, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3750.