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Parker Quality & Compliance

PQC Reg Watch

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510(k) clearance

Elos Accurate Hybrid Base

FDA 510(k) source

510(k) number
K261327
Applicant
Elos Medtech Pinol A/S
Decision date
Sep 30, 2026
Date received
Apr 22, 2026
Decision
Substantially Equivalent
Clearance type
Traditional
Product code
NHA
Device type
Abutment, Implant, Dental, Endosseous
Device class
Class II
Regulation
21 CFR 872.3630
Advisory committee
Dental
Statement or summary
Summary
Third party
N
Location
Goerloese, DK