SMARTmatic

Handpiece, Belt And/or Gear Driven, Dental

Kaltenbach & Voigt GmbH

The following data is part of a premarket notification filed by Kaltenbach & Voigt Gmbh with the FDA for Smartmatic.

Pre-market Notification Details

• Device ID: K163239
• 510k Number: K163239
• Device Name: SMARTmatic
• Classification: Handpiece, Belt And/or Gear Driven, Dental
• Applicant: Kaltenbach & Voigt GmbH Bismarckring 39 Biberach, DE 88400
• Contact: Stefan Trampler
• Correspondent: Stefan Trampler; Kaltenbach & Voigt GmbH Bismarckring 39 Biberach, DE 88400
• Product Code: EFA
• CFR Regulation Number: 872.4200 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-11-18
• Decision Date: 2017-03-17
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
EKAV101167800	K163239	000
EKAV101167860	K163239	000
EKAV101167300	K163239	000
EKAV101167310	K163239	000
EKAV101167320	K163239	000
EKAV101167400	K163239	000
EKAV101167410	K163239	000
EKAV101167500	K163239	000
EKAV101167510	K163239	000
EKAV101167520	K163239	000
EKAV101167600	K163239	000
EKAV101167710	K163239	000
EKAV101167900	K163239	000
EKAV101168000	K163239	000
EKAV101168100	K163239	000
10194665004507	K163239	000