Cleared Traditional

K780301 - CAULK TYLOK

K780301 is an FDA 510(k) clearance for CAULK TYLOK, manufactured by L.D. Caulk Co.. The device is a Class 2 Dental device with product code EMA cleared through the Traditional 510(k) pathway after a 6-day FDA review.

K780301 · L.D. Caulk Co. · Dental device
Download Printable Device Report (PDF)
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Feb 1978
Decision
6d
Days
Class 2
Risk

K780301 is an FDA 510(k) clearance for the CAULK TYLOK. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by L.D. Caulk Co. (Mchenry, US). The FDA issued a Cleared decision on February 28, 1978 after a review of 6 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 L.D. Caulk Co. devices

FDA 510(k) Submission Details - K780301

510(k) Number K780301 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 1978
Decision Date February 28, 1978
Days to Decision 6 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
121d faster than avg
Panel avg: 127d · This submission: 6d
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 354
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K780301.
CHEMBOND
K790586 · L.D. Caulk Co. · May 1979
KETAC APPLIC-CAPSULES
K790832 · Espe GmbH (Us) · Apr 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
ESPETEMP (TEMP. CEMENT)
K770923 · Espe GmbH (Us) · Jun 1977