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 IDK212932
510k NumberK212932
Device Name:Nobel Biocare NobelSpeedy Groovy / Branemark System Mk III TiUnite / Replace Select TC PureSet Tray
ClassificationSterilization Wrap Containers, Trays, Cassettes & Other Accessories
Applicant Nobel Biocare Services AG BOX 5190, SE-402 26, Vastra Hamngatan 1 Goteborg,  SE Se-411 17
ContactNick Lewis
CorrespondentNick Lewis
Nobel Biocare Services AG BOX 5190, SE-402 26, Vastra Hamngatan 1 Goteborg,  SE Se-411 17
Product CodeKCT  
CFR Regulation Number880.6850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-09-15
Decision Date2021-12-18

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.