Nobel Biocare NobelSpeedy Groovy / Branemark System Mk III TiUnite / Replace Select TC PureSet Tray

Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

Nobel Biocare Services AG

The following data is part of a premarket notification filed by Nobel Biocare Services Ag with the FDA for Nobel Biocare Nobelspeedy Groovy / Branemark System Mk Iii Tiunite / Replace Select Tc Pureset Tray.

Pre-market Notification Details

• Device ID: K212932
• 510k Number: K212932
• Device Name: Nobel Biocare NobelSpeedy Groovy / Branemark System Mk III TiUnite / Replace Select TC PureSet Tray
• Classification: Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
• Applicant: Nobel Biocare Services AG BOX 5190, SE-402 26, Vastra Hamngatan 1 Goteborg, SE Se-411 17
• Contact: Nick Lewis
• Correspondent: Nick Lewis; Nobel Biocare Services AG BOX 5190, SE-402 26, Vastra Hamngatan 1 Goteborg, SE Se-411 17
• Product Code: KCT
• CFR Regulation Number: 880.6850 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2021-09-15
• Decision Date: 2021-12-18

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07332747178920	K212932	000
07332747178913	K212932	000