Cleared Traditional

K973353 - BONDING BASE

K973353 is the FDA 510(k) clearance for BONDING BASE by Straumann USA. It is a Class 2 Dental device (product code DZE) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K973353 · Straumann USA · Dental device
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Dec 1997
Decision
88d
Days
Class 2
Risk

K973353 is an FDA 510(k) clearance for the BONDING BASE. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Straumann USA (Waltham, US). The FDA issued a Cleared decision on December 2, 1997 after a review of 88 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Straumann USA devices

Submission Details

510(k) Number K973353 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 1997
Decision Date December 02, 1997
Days to Decision 88 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
39d faster than avg
Panel avg: 127d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 672
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K973353.
STERI-OSS 3.25 MM REPLACE(HYDROXYAPATITE-COATED)DENTAL IMPLANT
K973423 · Steri-Oss, Inc. · Dec 1997
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K973771 · Implant Innovations, Inc. · Dec 1997
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K973402 · Steri-Oss, Inc. · Nov 1997
BRANEMARK SYSTEM ZYGOMATICUS FIXTURE SYSTEM
K970499 · Nobel Biocare Uas, Inc. · Oct 1997
THE MAESTRO SYSTEM
K972313 · BioHorizons Implant Systems, Inc. · Sep 1997