Cleared Traditional

K953775 - BRANDEMARK ACCESSORIES TO CERAMIC ABUTY...

K953775 is the FDA 510(k) clearance for BRANDEMARK ACCESSORIES TO CERAMIC ABUTY... by Nobelpharma USA, Inc.. It is a Class 2 Dental device (product code DZE) cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K953775 · Nobelpharma USA, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1995
Decision
38d
Days
Class 2
Risk

K953775 is an FDA 510(k) clearance for the BRANDEMARK ACCESSORIES TO CERAMIC ABUTYMENT (CERAMICORE). Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Nobelpharma USA, Inc. (Westmont, US). The FDA issued a Cleared decision on September 21, 1995 after a review of 38 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 Nobelpharma USA, Inc. devices

Submission Details

510(k) Number K953775 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 1995
Decision Date September 21, 1995
Days to Decision 38 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
89d faster than avg
Panel avg: 127d · This submission: 38d
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 673
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K953775.
BRANEMARK RADIOGRAPHIC DEPTH GUAGE
K953435 · Nobelpharma USA, Inc. · Oct 1995
3I STANDARD THREADED/SELF-TAPPING THREADED IMPLANTS, MINIPLANTS (TM)
K950204 · Implant Innovations, Inc. · Sep 1995
BRANEMARK RESTORATIVE INSTRUMENT & COMPONENT TRAY
K953774 · Nobelpharma USA, Inc. · Sep 1995
ABUTMENT
K953836 · Steri-Oss, Inc. · Sep 1995
BRANEMARK SYSTEM DRILLS AND COUNTERSINKS
K952685 · Nobelpharma USA, Inc. · Sep 1995
BRANEMARK SYSTEM OVOID & U-SHAPED BAR SYSTEM
K952886 · Nobelpharma USA, Inc. · Sep 1995