P.004 ABUTMENTS, P.004 TEMPORARY COPINGS, P.004 PROTECTIVE CAPS, P.004 PERMANENT COPINGS

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 Abutments, P.004 Temporary Copings, P.004 Protective Caps, P.004 Permanent Copings.

Pre-market Notification Details

• Device ID: K080239
• 510k Number: K080239
• Device Name: P.004 ABUTMENTS, P.004 TEMPORARY COPINGS, P.004 PROTECTIVE CAPS, P.004 PERMANENT COPINGS
• 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: 2008-01-31
• Decision Date: 2008-04-30
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07630031708151	K080239	000
07630031709202	K080239	000
07630031709219	K080239	000
07630031709417	K080239	000
07630031709424	K080239	000
07630031709431	K080239	000
07630031709448	K080239	000
07630031709455	K080239	000
07630031709462	K080239	000
07630031709479	K080239	000
07630031709486	K080239	000
07630031709493	K080239	000
07630031709196	K080239	000
07630031709189	K080239	000
07630031708168	K080239	000
07630031708175	K080239	000
07630031708182	K080239	000
07630031708199	K080239	000
07630031708205	K080239	000
07630031708496	K080239	000
07630031708502	K080239	000
07630031708922	K080239	000
07630031708939	K080239	000
07630031708946	K080239	000
07630031709172	K080239	000
07630031709509	K080239	000
07630031709516	K080239	000
07630031709523	K080239	000
07630031710291	K080239	000
07630031710376	K080239	000
07630031710383	K080239	000
07630031710390	K080239	000
07630031710406	K080239	000
07630031710734	K080239	000
07630031710741	K080239	000
07630031710826	K080239	000
07630031710833	K080239	000
07630031710857	K080239	000
07630031710864	K080239	000
07630031710284	K080239	000
07630031709950	K080239	000
07630031709684	K080239	000
07630031709691	K080239	000
07630031709707	K080239	000
07630031709714	K080239	000
07630031709721	K080239	000
07630031709738	K080239	000
07630031709745	K080239	000
07630031709752	K080239	000
07630031709912	K080239	000
07630031709929	K080239	000
07630031709943	K080239	000
07630031711052	K080239	000