Cleared Special

K981516 - STERNGOLD IMPLAMED HEX SCREW IMPLANT TP...

K981516 is an FDA 510(k) clearance for STERNGOLD IMPLAMED HEX SCREW IMPLANT TP..., manufactured by Sterngold/Implamed. The device is a Class 2 Dental device with product code DZE cleared through the Special 510(k) pathway after a 13-day FDA review.

K981516 · Sterngold/Implamed · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1998
Decision
13d
Days
Class 2
Risk

K981516 is an FDA 510(k) clearance for the STERNGOLD IMPLAMED HEX SCREW IMPLANT TPS COATED STERNGOLD IMPLAMED HEX SCREW .... Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Sterngold/Implamed (Attleboro, US). The FDA issued a Cleared decision on May 11, 1998 after a review of 13 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3640 - the FDA dental device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Sterngold/Implamed devices

FDA 510(k) Submission Details - K981516

510(k) Number K981516 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 1998
Decision Date May 11, 1998
Days to Decision 13 days
Submission Type Special
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
114d faster than avg
Panel avg: 127d · This submission: 13d
Pathway characteristics
Modification to existing cleared device.

DZE Device Classification - Class 2, Special Controls

Product Code DZE Implant, Endosseous, Root-form
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3640
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 - DZE Implant, Endosseous, Root-form

All 699
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K981516.
ASTRA TECH IMPLANT DENTAL SYSTEM
K974738 · Astra Tech, Inc. · Nov 1998
3I ORTHODONTIC ABUTMENT, ORTHOBUTMENT
K980083 · Implant Innovations, Inc. · Aug 1998
BRANEMARK SYSTEM DEC 600 DRILLING UNIT
K974123 · Nobel Biocare Uas, Inc. · May 1998
ONPLANT ORTHODONTIC SYSTEM
K980460 · Nobel Biocare Uas, Inc. · May 1998
OSSEOTITE DENTAL IMPLANT SYSTEM
K980549 · Implant Innovations, Inc. · Apr 1998
ASTRA TECH IMPLANT DENTAL SYSTEM
K974737 · Astra Tech, Inc. · Mar 1998