Adpharma Occlude and Occlude F Dentin Tubule Agent
FDA 510(k) K082071 · Adpharma, Inc.
510(k) numberK082071
Submission
- Device name
- Adpharma Occlude and Occlude F Dentin Tubule Agent
- Applicant
- Adpharma, Inc.
Arlington Heights, IL, US - Received
- July 22, 2008
- Decision date
- October 2, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K243777 | Rennou Varnish (3% / Spearmint); Rennou Varnish (3% / Strawberry); Rennou Varnish (3%…LBH · Traditional | Theodent, LLC | 05/27/2025SE |
| K241489 | ReminGelLBH · Traditional | Inter-Med, Inc. | 01/08/2025SE |
| K241568 | CrystLCare PRO Biorestorative, Fluoride-PlusLBH · Traditional | GreenMark Biomedical, Inc. | 01/02/2025SE |
| K242913 | Jasmate® ToothpasteLBH · Traditional | Jasberry Healthcare Private Limited | 11/22/2024SE |
Questions and answers
When was Adpharma Occlude and Occlude F Dentin Tubule Agent cleared by the FDA?
Adpharma Occlude and Occlude F Dentin Tubule Agent (K082071) received a 510(k) decision of Substantially Equivalent on October 2, 2008, 72 days after the submission was received.
What is the product code of K082071?
The FDA product code is LBH – Varnish, Cavity, a Class II (moderate risk) device regulated under 21 CFR 872.3260.