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510(k) K101029

KAIFENG/CRYSTAL, KAILI, KAIJING, KAIYUE, MAIST AND KAITONG/ROYAL SYNTHETIC POLYMER TEETH by Huge Dental Material Co., Ltd. — Product Code ELM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 16, 2010
Date Received
April 13, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Denture, Plastic, Teeth
Device Class
Class II
Regulation Number
872.3590
Review Panel
DE
Submission Type

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