KAIFENG/CRYSTAL, KAILI, KAIJING, KAIYUE, MAIST AND KAITONG/ROYAL SYNTHETIC POLYMER TEETH

Denture, Plastic, Teeth

HUGE DENTAL MATERIAL CO., LTD.

The following data is part of a premarket notification filed by Huge Dental Material Co., Ltd. with the FDA for Kaifeng/crystal, Kaili, Kaijing, Kaiyue, Maist And Kaitong/royal Synthetic Polymer Teeth.

Pre-market Notification Details

• Device ID: K101029
• 510k Number: K101029
• Device Name: KAIFENG/CRYSTAL, KAILI, KAIJING, KAIYUE, MAIST AND KAITONG/ROYAL SYNTHETIC POLYMER TEETH
• Classification: Denture, Plastic, Teeth
• Applicant: HUGE DENTAL MATERIAL CO., LTD. 3500 SOUTH DUPONT HIGHWAY Dover, DE 19901
• Contact: Jing Li
• Correspondent: Jing Li; HUGE DENTAL MATERIAL CO., LTD. 3500 SOUTH DUPONT HIGHWAY Dover, DE 19901
• Product Code: ELM
• CFR Regulation Number: 872.3590 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2010-04-13
• Decision Date: 2010-08-16
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
06970402677046	K101029	000
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06970402676902	K101029	000
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06970402660147	K101029	000
06970402660017	K101029	000