Cleared Traditional

K950203 - PROTEMP(R) GARANT

K950203 is an FDA 510(k) clearance for PROTEMP GARANT, manufactured by Espe GmbH & Co. Kg.. The device is a Class 2 Dental device with product code EBG cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K950203 · Espe GmbH & Co. Kg. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1995
Decision
15d
Days
Class 2
Risk

K950203 is an FDA 510(k) clearance for the PROTEMP(R) GARANT. Classified as Crown And Bridge, Temporary, Resin (product code EBG), Class II - Special Controls.

Submitted by Espe GmbH & Co. Kg. (Seefeld, DE). The FDA issued a Cleared decision on February 2, 1995 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3770 - 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 Espe GmbH & Co. Kg. devices

FDA 510(k) Submission Details - K950203

510(k) Number K950203 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 1995
Decision Date February 02, 1995
Days to Decision 15 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
112d faster than avg
Panel avg: 127d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBG Device Classification - Class 2, Special Controls

Product Code EBG Crown And Bridge, Temporary, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3770
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 - EBG Crown And Bridge, Temporary, Resin

All 122
Devices cleared under the same product code (EBG) and FDA review panel - the closest regulatory comparables to K950203.
BOSWORTH CH I
K961198 · Harry J. Bosworth Co. · May 1996
ALPHA-DENT TEMPORARY CROWN AND BRIDGE MATERIAL
K960122 · Wallace A. Erickson & Co. · Feb 1996
BELLEGLASHP
K955331 · Sybron Dental Specialties, Inc. · Jan 1996
3M TEMPCARE LIGHT CURE TEMPORARY SYSTEM
K944981 · 3M Company · Dec 1994
GC PATTERN RESIN
K942670 · GC America, Inc. · Oct 1994
STRUCTUR 2
K941124 · Voco GmbH · Apr 1994