Cleared Traditional

K131644 - ANKYLOS SYNCONE ABUTMENT 5(DEGREE)

K131644 is an FDA 510(k) clearance for ANKYLOS SYNCONE ABUTMENT 5(DEGREE), manufactured by Dentsply International, Inc.. The device is a Class 2 Dental device with product code NHA cleared through the Traditional 510(k) pathway after a 231-day FDA review.

K131644 · Dentsply International, Inc. · Dental device
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Jan 2014
Decision
231d
Days
Class 2
Risk

K131644 is an FDA 510(k) clearance for the ANKYLOS SYNCONE ABUTMENT 5(DEGREE). 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 Dentsply International, Inc. (York, US). The FDA issued a Cleared decision on January 22, 2014 after a review of 231 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 Dentsply International, Inc. devices

FDA 510(k) Submission Details - K131644

510(k) Number K131644 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 2013
Decision Date January 22, 2014
Days to Decision 231 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
104d slower than avg
Panel avg: 127d · This submission: 231d
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 649
Devices cleared under the same product code (NHA) and FDA review panel - the closest regulatory comparables to K131644.
NEODENT IMPLANT SYSTEM
K133696 · Jjgc Industria E Comercio DE Materiais Dentarios S · Feb 2014
STRAUMANN(R) VARIOBASE(TM) ABUTMENT NNC, STRAUMANN(R) VARIOBASE(TM) ABUTMENT RN, STRAUMANN(R) VARIOBASE(TM) ABUTMENT WN,
K132219 · Straumann USA, LLC · Feb 2014
NOBELPROCERA ANGULATED SCREW CHANNEL ABUTMENT CONICAL CONNECTION
K132746 · Nobel Biocare USA, LLC · Jan 2014
STRAUMANN CARES BONE LEVEL SCREW RETAINED BARS, STRAUMANN CARES BONE LEVEL SCREW RETAINED BRIDGES
K132844 · Straumann USA, LLC · Jan 2014
ET PROSTHETIC SYSTEM
K130662 · Osstem Implant Co., Ltd. · Jan 2014
MULTI ANGLED ABUTMENT SYSTEM
K132067 · Hiossen, Inc. · Dec 2013