Cleared Traditional

K903907 - PROCERAM PORCELAIN

K903907 is an FDA 510(k) clearance for PROCERAM PORCELAIN, manufactured by Nobelpharma USA, Inc.. The device is a Class 2 Dental device with product code ELL cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K903907 · Nobelpharma USA, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1990
Decision
78d
Days
Class 2
Risk

K903907 is an FDA 510(k) clearance for the PROCERAM PORCELAIN. Classified as Teeth, Porcelain (product code ELL), Class II - Special Controls.

Submitted by Nobelpharma USA, Inc. (Chicago, US). The FDA issued a Cleared decision on November 9, 1990 after a review of 78 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3920 - 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

FDA 510(k) Submission Details - K903907

510(k) Number K903907 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 1990
Decision Date November 09, 1990
Days to Decision 78 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 127d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ELL Device Classification - Class 2, Special Controls

Product Code ELL Teeth, Porcelain
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3920
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 - ELL Teeth, Porcelain

All 30
Devices cleared under the same product code (ELL) and FDA review panel - the closest regulatory comparables to K903907.
4% ACIDULATED PHOSPHATE FLUORIDE ETCHING GEL
K920460 · Pulpdent Corp. · Apr 1992
TYCERAMIC
K910569 · Jeneric/Pentron, Inc. · Apr 1991
SYSNPAR PORCELAIN
K910303 · Jeneric/Pentron, Inc. · Mar 1991
DEN-MAT LAMI-QUICK
K895269 · Den-Mat Corp. · Feb 1990
TUF-COAT
K892806 · G-C Intl. Corp. · Jul 1989
CRYSTAR(TM) ANTI-GREENING LIQUID
K893481 · Shofu Dental Corp. · Jul 1989