Cleared Traditional

K121810 - OSSEOSPEED ANGLED ABUTMENT EV

K121810 is an FDA 510(k) clearance for OSSEOSPEED ANGLED ABUTMENT EV, manufactured by Astra Tech AB. The device is a Class 2 Dental device with product code NHA cleared through the Traditional 510(k) pathway after a 217-day FDA review.

K121810 · Astra Tech AB · Dental device
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Jan 2013
Decision
217d
Days
Class 2
Risk

K121810 is an FDA 510(k) clearance for the OSSEOSPEED ANGLED ABUTMENT EV. 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 Astra Tech AB (San Diego, US). The FDA issued a Cleared decision on January 23, 2013 after a review of 217 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Astra Tech AB devices

FDA 510(k) Submission Details - K121810

510(k) Number K121810 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 2012
Decision Date January 23, 2013
Days to Decision 217 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
90d slower than avg
Panel avg: 127d · This submission: 217d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NHA Device Classification - Class 2, Special Controls

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 496
Devices cleared under the same product code (NHA) and FDA review panel - the closest regulatory comparables to K121810.
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