KAIFENG/CRYSTAL, KAILI, KAIJING, KAIYUE, MAIST AND KAITONG/ROYAL SYNTHETIC POLYMER TEETH— 510(k) K101029

Name: FDA 510(k) clearance K101029
Creator: U.S. Food and Drug Administration
Published: 2010-08-16

Substantially Equivalent

Huge Dental Material Co., Ltd.

FDA 510(k) clearance K101029 for KAIFENG/CRYSTAL, KAILI, KAIJING, KAIYUE, MAIST AND KAITONG/ROYAL SYNTHETIC POLYMER TEETH, Substantially Equivalent on 2010-08-16. Applicant: Huge Dental Material Co., Ltd.. Device class: 2.

Clearance details

Applicant: Huge Dental Material Co., Ltd.
Product code: Code ELM
Device class: Class 2
Regulation: 21 CFR 872.3590
Advisory panel: Dental
Date received: 2010-04-13
Decision date: 2010-08-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dover, DE, US

Download summary PDF View on FDA.gov ↗

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