Cleared Traditional

K800138 - TS-301 THREE-WAY PULP TESTER

K800138 is an FDA 510(k) clearance for TS-301 THREE-WAY PULP TESTER, manufactured by Tamler-Stoneham Instruments. The device is a Class 2 Dental device with product code EAT cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K800138 · Tamler-Stoneham Instruments · Dental device
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Feb 1980
Decision
23d
Days
Class 2
Risk

K800138 is an FDA 510(k) clearance for the TS-301 THREE-WAY PULP TESTER. Classified as Tester, Pulp (product code EAT), Class II - Special Controls.

Submitted by Tamler-Stoneham Instruments (Mchenry, US). The FDA issued a Cleared decision on February 13, 1980 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.1720 - 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 Tamler-Stoneham Instruments devices

FDA 510(k) Submission Details - K800138

510(k) Number K800138 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 1980
Decision Date February 13, 1980
Days to Decision 23 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
105d faster than avg
Panel avg: 128d · This submission: 23d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EAT Device Classification - Class 2, Special Controls

Product Code EAT Tester, Pulp
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.1720
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.