SMARTEMP

Crown And Bridge, Temporary, Resin

PARKELL, INC.

The following data is part of a premarket notification filed by Parkell, Inc. with the FDA for Smartemp.

Pre-market Notification Details

• Device ID: K991270
• 510k Number: K991270
• Device Name: SMARTEMP
• Classification: Crown And Bridge, Temporary, Resin
• Applicant: PARKELL, INC. 155 SCHMITT BLVD. P.O. BOX 376 Farmingdale, NY 11735
• Contact: Nelson J Gendusa
• Correspondent: Nelson J Gendusa; PARKELL, INC. 155 SCHMITT BLVD. P.O. BOX 376 Farmingdale, NY 11735
• Product Code: EBG
• CFR Regulation Number: 872.3770 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1999-04-13
• Decision Date: 1999-05-21
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00810000525317	K991270	000
00810000525300	K991270	000
00810000525294	K991270	000
00810000525287	K991270	000
10810000526953	K991270	000