Prime-Dent Visible Light Cure Pit & Fissure Sealant
FDA 510(k) K012761 · Prime Dental Manufacturing, Inc.
510(k) numberK012761
Submission
- Device name
- Prime-Dent Visible Light Cure Pit & Fissure Sealant
- Applicant
- Prime Dental Manufacturing, Inc.
Chicago, IL, US - Received
- August 17, 2001
- Decision date
- November 1, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| 510(k) | Device | Decision |
|---|---|---|
| K112574 | Prime-Dent Dual Cure Composite Luting CementEMA · Traditional | 01/23/2012SE |
| K022675 | Prime-Dent Automix Dual Cure Core Build Up MaterialEBF · Traditional | 11/07/2002SE |
| K021524 | Light Cure Dental DamEIE · Traditional | 07/19/2002SE |
| K013970 | Prime-Dent Hema DesensitizerEBF · Traditional | 02/19/2002SE |
| K012794 | Prime-Dent Chemical Cure Pit & Fissure SealantEBF · Traditional | 11/05/2001SE |
| K012673 | Prime-Dent One-Step Orthodontic Adhesive Bonding SystemDYH · Traditional | 10/24/2001SE |
| K001108 | Prime-Dent Visible Light Cure Composite Restorative MaterialEBF · Traditional | 05/30/2000SE |
| K994224 | Prime-Dent Chemical Cure Composite Restorative MaterialEBF · Traditional | 01/31/2000SE |
Questions and answers
When was Prime-Dent Visible Light Cure Pit & Fissure Sealant cleared by the FDA?
Prime-Dent Visible Light Cure Pit & Fissure Sealant (K012761) received a 510(k) decision of Substantially Equivalent on November 1, 2001, 76 days after the submission was received.
What is the product code of K012761?
The FDA product code is EBC – Sealant, Pit And Fissure, And Conditioner, a Class II (moderate risk) device regulated under 21 CFR 872.3765.