Cleared Traditional

K800060 - PROVIT

K800060 is an FDA 510(k) clearance for PROVIT, manufactured by Parker Laboratories, Inc.. The device is a Class 2 Dental device with product code EMA cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K800060 · Parker Laboratories, Inc. · Dental device
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Jan 1980
Decision
13d
Days
Class 2
Risk

K800060 is an FDA 510(k) clearance for the PROVIT. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Parker Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 23, 1980 after a review of 13 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3275 - 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 Parker Laboratories, Inc. devices

FDA 510(k) Submission Details - K800060

510(k) Number K800060 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 1980
Decision Date January 23, 1980
Days to Decision 13 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
114d faster than avg
Panel avg: 127d · This submission: 13d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EMA Device Classification - Class 2, Special Controls

Product Code EMA Cement, Dental
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3275
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 - EMA Cement, Dental

All 421
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K800060.
SILICAP
K801227 · Vivadent (Usa), Inc. · Aug 1980
BONDALCAP (SILICO-PHOSPHATE)
K801228 · Vivadent (Usa), Inc. · Jun 1980
BONDALCAP (CARBOXYLATE)
K801229 · Vivadent (Usa), Inc. · Jun 1980
DENTAL CEMENT, ZINC PHOSPHATE
K790593 · Wallace A. Erickson & Co. · Jun 1979
CHEMBOND
K790586 · L.D. Caulk Co. · May 1979
KETAC APPLIC-CAPSULES
K790832 · Espe GmbH (Us) · Apr 1979