Cleared Traditional

Nobel Biocare N1 PureSet Tray, Nobel Biocare N1 PureSet Plate, Prosthetic PureSet Tray, Prosthetic PureSet Plate

K191475 · Nobel Biocare AB · General Hospital

Aug 2019

Decision

86d

Days

Class 2

Risk

About This 510(k) Submission

K191475 is an FDA 510(k) clearance for the Nobel Biocare N1 PureSet Tray, Nobel Biocare N1 PureSet Plate, Prosthetic PureSet Tray, Prosthetic PureSet Plate, a Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (Class II — Special Controls, product code KCT), submitted by Nobel Biocare AB (Goteborg, SE). The FDA issued a Cleared decision on August 29, 2019, 86 days after receiving the submission on June 4, 2019. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6850.

Submission Details

510(k) Number	K191475 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 04, 2019
Decision Date	August 29, 2019
Days to Decision	86 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF

Device Classification

Product Code	KCT — Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 880.6850