Identifiers
- 510(k) Number
- K895750 FDA 510(k)
- FDA Product Code
- KLE FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3200 FDA 510(k)
- Regulation Number
- 872.3200 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
HEMA-PRIMER is an Agent, Tooth Bonding, Resin device used in dental applications. It is classified as a Class II medical device under FDA regulation 872.3200.
The device received FDA 510(k) clearance (K895750) on December 21, 1989, as substantially equivalent to a predicate device. It is manufactured by Parkell and assigned product code KLE, with no third-party review involved in its clearance.
Frequently asked questions
What is HEMA-PRIMER used for?
HEMA-PRIMER is an Agent, Tooth Bonding, Resin device used in dental applications to prepare tooth surfaces for bonding procedures, as indicated by its classification under FDA regulation 872.3200 for tooth bonding agents.
How was HEMA-PRIMER cleared for market release?
HEMA-PRIMER received FDA 510(k) clearance (K895750) on December 21, 1989, as substantially equivalent to a predicate device, with no third-party review involved in its clearance process.
Who manufactures HEMA-PRIMER and where is it produced?
HEMA-PRIMER is manufactured by Parkell, located at 155 Schmitt Blvd., P.O. Box 376, Farmingdale, NY 11735, United States, as specified in the device’s registration and listing information.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: HEMA-PRIMER (K895750) — FDA 510(k) | Innolitics, HEMA-PRIMER 510 (k) K895750 - FDA.report, 510 (k) K895750 — HEMA-PRIMER — RegDataLab, Hema-primer - Beudamed
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K895750 | Class II | Active |
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Manufacturer
- Manufacturer
- Parkell
Sources (1)
- FDA 510(k) K895750 24 fields · synced Sep 26, 2026