Product code KLE: 510(k) clearances and predicates
Product code KLE covers MPa Max adhesive. FDA lists 420 clearances under this code in the 510(k) index. This page summarizes recent clearance volume and names recent clearances by K number so you can pick predicates faster.
Clearance volume
420 clearances on file under product code KLE. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 8 |
| 2023 | 6 |
| 2024 | 7 |
| 2025 | 3 |
| 2026 so far | 6 |
Recent clearances
Newest KLE clearances in the FDA index, with applicant and decision date:
- K262252, MPa Max adhesive, applicant Den-Mat Holdings, LLC, decided 2026-09-24. FDA record
- K260485, Any-Etch, applicant Mediclus Co., Ltd., decided 2026-05-14. FDA record
- K260430, Porcelain Etch Gel, applicant Belport Company, Inc., Gingi-Pak, decided 2026-04-10. FDA record
- K252450, Adhese 2, applicant Ivoclar Vivadent, Inc., decided 2026-03-05. FDA record
- K260682, Bond-PR™ Universal Adhesive, applicant Premier Dental Products Company, decided 2026-03-03. FDA record
- K251587, VITA VMLC Primer, applicant Vita Zahnfabrik H. Rauter GmbH & Co. Kg., decided 2026-02-23. FDA record
- K252151, els unibond, applicant Saremco Dental AG, decided 2025-12-05. FDA record
- K252469, MAGNABOND SE; MAGNABOND UNIVERSAL; MAGNABOND UNIVERSAL DCA, applicant Dmp Dental Industry S.A., decided 2025-11-06. FDA record
What this means for a regulatory watcher
Volume tells you how deep the predicate pool is. A code with steady yearly counts gives you many candidate predicates, which helps when one predicate has a recall or design gap. A code with a sharp recent rise means reviewers are seeing more of this device type, so substantial equivalence arguments need to track the newest cleared devices, not five year old ones. Related device names in recent clearances include Any-Etch, Porcelain Etch Gel. Watch new KLE clearances as they post: each one is a possible predicate for your submission and a possible competitor worth reading.
FAQ
What is FDA product code KLE?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent KLE clearances include MPa Max adhesive.
How many 510(k) clearances use product code KLE?
420 at the time this page was generated, from openFDA records.
How do I find a predicate device under KLE?
Start with the recent K numbers listed above, then run the free predicate search to check substantial equivalence text and review history.
How do I track new KLE clearances?
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.