Tubulitec Primer
FDA 510(k) K851052 · Dental Therapeutics AB
510(k) numberK851052
Submission
- Device name
- Tubulitec Primer
- Applicant
- Dental Therapeutics AB
Nacka, SE - Received
- March 14, 1985
- Decision date
- July 31, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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 |
More from Jasberry Healthcare Private Limited
| 510(k) | Device | Decision |
|---|---|---|
| K851053 | Tubulitec LinerEJK · Traditional | 07/25/1985SE |
Questions and answers
When was Tubulitec Primer cleared by the FDA?
Tubulitec Primer (K851052) received a 510(k) decision of Substantially Equivalent on July 31, 1985, 139 days after the submission was received.
What is the product code of K851052?
The FDA product code is LBH – Varnish, Cavity, a Class II (moderate risk) device regulated under 21 CFR 872.3260.