Cleared Traditional

K914178 - CORRECTED-V.P.S.

K914178 is an FDA 510(k) clearance for CORRECTED-V.P.S., manufactured by Jeneric/Pentron, Inc.. The device is a Class 2 Dental device with product code ELW cleared through the Traditional 510(k) pathway after a 223-day FDA review.

K914178 · Jeneric/Pentron, Inc. · Dental device
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Apr 1992
Decision
223d
Days
Class 2
Risk

K914178 is an FDA 510(k) clearance for the CORRECTED-V.P.S.. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Jeneric/Pentron, Inc. (Wallingford, US). The FDA issued a Cleared decision on April 28, 1992 after a review of 223 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3660 - 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 Jeneric/Pentron, Inc. devices

FDA 510(k) Submission Details - K914178

510(k) Number K914178 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 1991
Decision Date April 28, 1992
Days to Decision 223 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
96d slower than avg
Panel avg: 127d · This submission: 223d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ELW Device Classification - Class 2, Special Controls

Product Code ELW Material, Impression
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3660
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 - ELW Material, Impression

All 195
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K914178.
VINYL POLYSILOXANE IMPRESSION SYSTEM AND RE'CORD
K926033 · Harry J. Bosworth Co. · May 1993
TRIANGULAR JAW MICROLARYNGEAL FORCEPS
K925370 · Pilling Co. · Mar 1993
Q3 (LIGHT AND UNIVERSAL) IMPRESSION MATERIAL
K923202 · Jeneric/Pentron, Inc. · Aug 1992
VITA CEREC SET AND VITA CEREC BLOCS
K895901 · Vident · Jan 1992
CORRECT-S.I.M.
K914437 · Jeneric/Pentron, Inc. · Jan 1992
MEMOSIL C.D.
K913537 · Heraeus Kulzer, Inc. · Oct 1991