WILLI GELLER CREAPEARL

Denture, Plastic, Teeth

JENSEN INDUSTRIES, INC.

The following data is part of a premarket notification filed by Jensen Industries, Inc. with the FDA for Willi Geller Creapearl.

Pre-market Notification Details

• Device ID: K010160
• 510k Number: K010160
• Device Name: WILLI GELLER CREAPEARL
• Classification: Denture, Plastic, Teeth
• Applicant: JENSEN INDUSTRIES, INC. 50 STILLMAN RD. North Haven, CT 06473
• Contact: John Slanski
• Correspondent: John Slanski; JENSEN INDUSTRIES, INC. 50 STILLMAN RD. North Haven, CT 06473
• Product Code: ELM
• CFR Regulation Number: 872.3590 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2001-01-16
• Decision Date: 2001-03-27

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
ECWGC300300V651	K010160	000
ECWGA300700A731	K010160	000
ECWGA300600A711	K010160	000
ECWGA300500V691	K010160	000
ECWGA201500U901	K010160	000
ECWGA201000A791	K010160	000
ECWGA200900A781	K010160	000
ECWGA200800A751	K010160	000
ECWGA200100V611	K010160	000
ECWGA300800A751	K010160	000
ECWGA300900A781	K010160	000
ECWGA301000A791	K010160	000
ECWGB200300V651	K010160	000
ECWGA351400U701	K010160	000
ECWGA351100U101	K010160	000
ECWGA350800A751	K010160	000
ECWGA350400V681	K010160	000
ECWGA350300V651	K010160	000
ECWGA301500U901	K010160	000
ECWGA301200U301	K010160	000
ECWGA100900A781	K010160	000