Cleared Traditional

K082545 - STRAUMANN NN CARES TITANIUM AND CERAMIC...

K082545 is the FDA 510(k) clearance for STRAUMANN NN CARES TITANIUM AND CERAMIC... by Institut Straumann AG. It is a Class 2 Dental device (product code NHA) cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K082545 · Institut Straumann AG · Dental device
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Oct 2008
Decision
44d
Days
Class 2
Risk

K082545 is an FDA 510(k) clearance for the STRAUMANN NN CARES TITANIUM AND CERAMIC ABUTMENTS. Classified as Abutment, Implant, Dental, Endosseous within the NHA classification (a category for dental implant abutments and prosthetic components), Class II - Special Controls.

Submitted by Institut Straumann AG (Andover, US). The FDA issued a Cleared decision on October 17, 2008 after a review of 44 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3630 - the FDA dental device regulatory 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 Institut Straumann AG devices

Submission Details

510(k) Number K082545 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 2008
Decision Date October 17, 2008
Days to Decision 44 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 127d · This submission: 44d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NHA Abutment, Implant, Dental, Endosseous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3630
Definition To Be Used In Conjunction With An Endosseous Dental Implant Fixture To Aid In Prosthetic Rehabilitation.
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 Dental devices follow this clearance model.

Regulatory Peers - NHA Abutment, Implant, Dental, Endosseous

All 463
Devices cleared under the same product code (NHA) and FDA review panel - the closest regulatory comparables to K082545.
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