METAL-LINED TRANSCEND CERAMIC BRACKET

Bracket, Plastic, Orthodontic

UNITEK CORP.

The following data is part of a premarket notification filed by Unitek Corp. with the FDA for Metal-lined Transcend Ceramic Bracket.

Pre-market Notification Details

• Device ID: K944286
• 510k Number: K944286
• Device Name: METAL-LINED TRANSCEND CERAMIC BRACKET
• Classification: Bracket, Plastic, Orthodontic
• Applicant: UNITEK CORP. 2724 SOUTH PECK RD. Monrovia, CA 91016 -5097
• Contact: Marlyn Scheff
• Correspondent: Marlyn Scheff; UNITEK CORP. 2724 SOUTH PECK RD. Monrovia, CA 91016 -5097
• Product Code: DYW
• CFR Regulation Number: 872.5470 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1994-09-02
• Decision Date: 1994-11-29

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00652221168771	K944286	000
00652221168962	K944286	000
00652221168979	K944286	000
00652221168986	K944286	000
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00652221169006	K944286	000
00652221169013	K944286	000
00652221169020	K944286	000
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00652221168948	K944286	000
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00652221168894	K944286	000
00652221168900	K944286	000
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00652221169365	K944286	000
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00652221169389	K944286	000
00652221169396	K944286	000
00652221169402	K944286	000
00652221169419	K944286	000
00652221217875	K944286	000
00652221217882	K944286	000
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00652221169266	K944286	000
00652221169273	K944286	000
00652221169280	K944286	000
00652221169297	K944286	000
00652221169303	K944286	000
00652221169310	K944286	000
00652221227409	K944286	000