Cleared Traditional

K153509 - GPS Angled Abutment

K153509 is an FDA 510(k) clearance for GPS Angled Abutment, manufactured by Implant Direct Sybron Manufacturing, LLC. The device is a Class 2 Dental device with product code NHA cleared through the Traditional 510(k) pathway after a 263-day FDA review.

K153509 · Implant Direct Sybron Manufacturing, LLC · Dental device
Download Printable Device Report (PDF)
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Aug 2016
Decision
263d
Days
Class 2
Risk

K153509 is an FDA 510(k) clearance for the GPS Angled 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 Implant Direct Sybron Manufacturing, LLC (Thousand Oaks, US). The FDA issued a Cleared decision on August 26, 2016 after a review of 263 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 Implant Direct Sybron Manufacturing, LLC devices

FDA 510(k) Submission Details - K153509

510(k) Number K153509 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 2015
Decision Date August 26, 2016
Days to Decision 263 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
136d slower than avg
Panel avg: 127d · This submission: 263d
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 534
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