Cleared Traditional

K921010 - STERN ERA ALIGNMENT CORRECTION IMPLANT ABUTMENT

K921010 is an FDA 510(k) clearance for STERN ERA ALIGNMENT CORRECTION IMPLANT ..., manufactured by Apm Stern Gold. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 182-day FDA review.

K921010 · Apm Stern Gold · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1992
Decision
182d
Days
Class 2
Risk

K921010 is an FDA 510(k) clearance for the STERN ERA ALIGNMENT CORRECTION IMPLANT ABUTMENT. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Apm Stern Gold (North Attleboro, US). The FDA issued a Cleared decision on September 1, 1992 after a review of 182 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3640 - 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 Apm Stern Gold devices

FDA 510(k) Submission Details - K921010

510(k) Number K921010 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 1992
Decision Date September 01, 1992
Days to Decision 182 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
55d slower than avg
Panel avg: 127d · This submission: 182d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 1322
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K921010.
BRANEMARK SYSTEM HEALING CAPS
K925780 · Nobelpharma USA, Inc. · Apr 1993
HEXLOCK SCREW
K920909 · Imtec Corp. · Jan 1993
INTERPORE IMZ CYLINDER IMPLANT SYSTEM
K913228 · Interpore Intl. · Oct 1992
ANGULATED ABUTMENT, COMPLETE,TITANIUM SDCA 102
K905434 · Nobelpharma USA, Inc. · Aug 1992
STERI-OSS DRILLS AND TAPS
K915733 · Steri-Oss, Inc. · Jul 1992
O BUTMENT HB
K921933 · "O" Co., Inc. · Jul 1992