Cleared Traditional

K151432 - NaturalLine Abutment

K151432 is an FDA 510(k) clearance for NaturalLine Abutment, manufactured by Ot Medical GmbH. The device is a Class 2 Dental device with product code NHA cleared through the Traditional 510(k) pathway after a 161-day FDA review.

K151432 · Ot Medical GmbH · Dental device
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Nov 2015
Decision
161d
Days
Class 2
Risk

K151432 is an FDA 510(k) clearance for the NaturalLine Abutment. 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 Ot Medical GmbH (Bremen, DE). The FDA issued a Cleared decision on November 5, 2015 after a review of 161 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.

FDA 510(k) Submission Details - K151432

510(k) Number K151432 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 2015
Decision Date November 05, 2015
Days to Decision 161 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
33d slower than avg
Panel avg: 128d · This submission: 161d
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 715
Devices cleared under the same product code (NHA) and FDA review panel - the closest regulatory comparables to K151432.
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K151798 · Prismatik Dentalcraft, Inc. · Nov 2015
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K150669 · Neoss, Ltd. · Oct 2015
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K151169 · Osteoready, LLC · Oct 2015