Cleared Traditional

K790832 - KETAC APPLIC-CAPSULES

K790832 is an FDA 510(k) clearance for KETAC APPLIC-CAPSULES, manufactured by Espe GmbH (Us). The device is a Class 2 Dental device with 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

FDA 510(k) Submission Details - K790832

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.

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 433
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K790832.
PROVIT
K800060 · Parker Laboratories, Inc. · Jan 1980
DENTAL CEMENT, ZINC PHOSPHATE
K790593 · Wallace A. Erickson & Co. · Jun 1979
CHEMBOND
K790586 · L.D. Caulk Co. · May 1979
CEMENT, CERAMCO
K790127 · Johnson & Johnson Professionals, Inc. · Feb 1979
CAULK TYLOK
K780301 · L.D. Caulk Co. · Feb 1978
TONGUE BLADE HOLDER
K771481 · Welch Allyn, Inc. · Aug 1977