P.004 RC TEMPORARY ABUTMENT, P.004 TEMPORARY HEALING ABUTMENT (CAP)

Abutment, Implant, Dental, Endosseous

STRAUMANN MANUFACTURING, INC.

The following data is part of a premarket notification filed by Straumann Manufacturing, Inc. with the FDA for P.004 Rc Temporary Abutment, P.004 Temporary Healing Abutment (cap).

Pre-market Notification Details

• Device ID: K070478
• 510k Number: K070478
• Device Name: P.004 RC TEMPORARY ABUTMENT, P.004 TEMPORARY HEALING ABUTMENT (CAP)
• Classification: Abutment, Implant, Dental, Endosseous
• Applicant: STRAUMANN MANUFACTURING, INC. 60 MINUTEMAN RD. Andover, MA 01810
• Contact: Elaine Alan
• Correspondent: Elaine Alan; STRAUMANN MANUFACTURING, INC. 60 MINUTEMAN RD. Andover, MA 01810
• Product Code: NHA
• CFR Regulation Number: 872.3630 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2007-02-20
• Decision Date: 2007-09-20
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07630031710888	K070478	000
07630031710710	K070478	000