Cleared Traditional

K802235 - MICRO-BOND HI-LIFE PROCELAIN & VIVERE

K802235 is an FDA 510(k) clearance for MICRO-BOND HI-LIFE PROCELAIN & VIVERE, manufactured by Howmedica Corp.. The device is a Class 2 Dental device with product code EIH cleared through the Traditional 510(k) pathway after a 11-day FDA review.

K802235 · Howmedica Corp. · Dental device
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Sep 1980
Decision
11d
Days
Class 2
Risk

K802235 is an FDA 510(k) clearance for the MICRO-BOND HI-LIFE PROCELAIN & VIVERE. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Howmedica Corp. (Mchenry, US). The FDA issued a Cleared decision on September 26, 1980 after a review of 11 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6660 - 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 Howmedica Corp. devices

FDA 510(k) Submission Details - K802235

510(k) Number K802235 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 1980
Decision Date September 26, 1980
Days to Decision 11 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
116d faster than avg
Panel avg: 127d · This submission: 11d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EIH Device Classification - Class 2, Special Controls

Product Code EIH Powder, Porcelain
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.6660
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 - EIH Powder, Porcelain

All 401
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K802235.
LUXOR PORCELAIN
K820057 · Jeneric Ind. · Mar 1982
PORCELAIN POWDER FOR CLINICAL USE
K810096 · Dentsply Intl. · Mar 1981
CERAMCO PORCELAIN
K803310 · Johnson & Johnson Professionals, Inc. · Jan 1981
ACCU-PAQUE
K771886 · Williams Gold Refining Co., Inc. · Nov 1977
ACCU-STAIN
K771887 · Williams Gold Refining Co., Inc. · Nov 1977
GERAMCO LOW TEMP GLAZE
K770932 · Johnson & Johnson Professionals, Inc. · Jun 1977