Product code EMA: 510(k) clearances and predicates
Product code EMA covers EsTemp Implant. FDA lists 509 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
509 clearances on file under product code EMA. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 7 |
| 2023 | 2 |
| 2024 | 3 |
| 2025 | 10 |
| 2026 so far | 7 |
Recent clearances
Newest EMA clearances in the FDA index, with applicant and decision date:
- K262983, EsTemp Implant, applicant Spident Co., Ltd., decided 2026-09-25. FDA record
- K254201, Any-Cem, applicant Mediclus Co., Ltd., decided 2026-08-13. FDA record
- K261937, PacTemp Automix NE, applicant The Belport Company Inc., DBA Gingi-Pak, decided 2026-08-07. FDA record
- K261166, DIA-CEM, applicant DiaDent Group International, decided 2026-07-09. FDA record
- K254109, G-CEM UNIVERSAL, applicant GC America, Inc., decided 2026-05-18. FDA record
- K253337, REGEN Bioactive Cement, applicant Inter-Med, Inc., decided 2026-04-15. FDA record
- K252606, Bifix Veneer LC, Bifix Veneer Try-In, applicant Voco GmbH, decided 2026-03-20. FDA record
- K254063, iCEM Universal Plus, applicant Kulzer, LLC, decided 2025-12-19. 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-Cem, PacTemp Automix NE. Watch new EMA 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 EMA?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent EMA clearances include EsTemp Implant.
How many 510(k) clearances use product code EMA?
509 at the time this page was generated, from openFDA records.
How do I find a predicate device under EMA?
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 EMA clearances?
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.