Cleared Traditional

K970073 - BIO-ESTHETIC INDIRECT ABUTMENT

K970073 is an FDA 510(k) clearance for BIO-ESTHETIC INDIRECT ABUTMENT, manufactured by Steri-Oss, Inc.. The device is a Class 2 Dental device with product code NHA cleared through the Traditional 510(k) pathway after a 176-day FDA review.

K970073 · Steri-Oss, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1997
Decision
176d
Days
Class 2
Risk

K970073 is an FDA 510(k) clearance for the BIO-ESTHETIC INDIRECT 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 Steri-Oss, Inc. (Yorba Linda, US). The FDA issued a Cleared decision on July 3, 1997 after a review of 176 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 Steri-Oss, Inc. devices

FDA 510(k) Submission Details - K970073

510(k) Number K970073 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 08, 1997
Decision Date July 03, 1997
Days to Decision 176 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
49d slower than avg
Panel avg: 127d · This submission: 176d
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 495
Devices cleared under the same product code (NHA) and FDA review panel - the closest regulatory comparables to K970073.
PROCERA PREPARABLE ABUTMENT SYSTEM
K974150 · Nobel Biocare Uas, Inc. · Jan 1998
AURADAPT AUBTMENT SYSTEM
K972475 · Nobel Biocare Uas, Inc. · Sep 1997
TIADAPT ABUTMENT SYSTEM
K971706 · Nobel Biocare Uas, Inc. · Jul 1997
17 ANGULATED ABUTMENT
K961736 · Nobelpharma USA, Inc. · Jul 1996
MIRUSCONE ABUTMENT SYSTEM
K961728 · Nobelpharma USA, Inc. · Jul 1996
BRANEMARK SYSTEM TITANIUM HEALING ABUTMENTS
K925779 · Nobelpharma USA, Inc. · Apr 1993