Cleared Traditional

K790832 - KETAC APPLIC-CAPSULES

K790832 is the FDA 510(k) clearance for KETAC APPLIC-CAPSULES by Espe GmbH (Us). It is a Class 2 Dental device (product code EMA) cleared through the Traditional 510(k) pathway .

K790832 · Espe GmbH (Us) · Dental device
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Apr 1979
Decision
-
Days
Class 2
Risk

K790832 is an FDA 510(k) clearance for the KETAC APPLIC-CAPSULES. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Espe GmbH (Us) (Mchenry, US). The FDA issued a Cleared decision on April 30, 1979.

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: 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 Espe GmbH (Us) devices

Submission Details

510(k) Number K790832 FDA.gov
FDA Decision Cleared Substantially Equivalent - Product Development Protocol (SESP)
Date Received April 30, 1979
Decision Date April 30, 1979
Days to Decision -
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 292
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K790832.
HY-BOND ZINC PHOSPHATE CEMENT
K810765 · Shofu Dental Corp. · Jun 1981
PROVIT
K800060 · Parker Laboratories, Inc. · Jan 1980
DENTAL CEMENT, ZINC PHOSPHATE
K790593 · Wallace A. Erickson & Co. · Jun 1979
CEMENT, CERAMCO
K790127 · Johnson & Johnson Professionals, Inc. · Feb 1979
TONGUE BLADE HOLDER
K771481 · Welch Allyn, Inc. · Aug 1977
SCUTABOND
K771451 · Premier Dental Products Co. · Aug 1977