Cleared Traditional

K191475 - Nobel Biocare N1 PureSet Tray

K191475 is the FDA 510(k) clearance for Nobel Biocare N1 PureSet Tray by Nobel Biocare AB. It is a Class 2 General Hospital device (product code KCT) cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K191475 · Nobel Biocare AB · General Hospital
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Optimized for regulatory review, auditing and printing
Aug 2019
Decision
86d
Days
Class 2
Risk

K191475 is an FDA 510(k) clearance for the Nobel Biocare N1 PureSet Tray, Nobel Biocare N1 PureSet Plate, Prosthetic Pur.... Classified as Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (product code KCT), Class II - Special Controls.

Submitted by Nobel Biocare AB (Goteborg, SE). The FDA issued a Cleared decision on August 29, 2019 after a review of 86 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6850 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Nobel Biocare AB devices

Submission Details

510(k) Number K191475 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 129d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6850
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Consultant

Nobel Biocare Services AG
Elena Cavallini

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

All 161
Devices cleared under the same product code (KCT) and FDA review panel - the closest regulatory comparables to K191475.
Pivot System Sterilization case
K181845 · Rp Medical, Inc. · Nov 2019
MTS225 and MTS300 Multiple Tray Sterilization Systems
K190541 · Pmbs, LLC · Nov 2019
Medtronic Transportation / Sterilization Cassettes
K190840 · Medtronic Sofamor Danek USA, Inc. · Oct 2019
Aesculap® SterilContainer(TM) S2 System
K182414 · Aesculap, Inc. · Jul 2019
Sonopet iQ Sterilization Tray
K190667 · Paragon Medical · Jun 2019
DePuy Synthes Sterilization Container System
K181933 · Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. · May 2019