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Parker Quality & Compliance

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510(k) clearance

Amber Arte

FDA 510(k) source

510(k) number
K262523
Applicant
Hass Corp.
Decision date
Oct 16, 2026
Date received
Jul 22, 2026
Decision
Substantially Equivalent
Clearance type
Traditional
Product code
EIH
Device type
Powder, Porcelain
Device class
Class II
Regulation
21 CFR 872.6660
Advisory committee
Dental
Statement or summary
Summary
Third party
N
Location
Gangneung, KR