Cleared Traditional

K771114 - NEUTROCIM

K771114 is an FDA 510(k) clearance for NEUTROCIM, manufactured by Septodont, Inc.. The device is a Class 2 Dental device with product code EMA cleared through the Traditional 510(k) pathway after a 197-day FDA review.

K771114 · Septodont, Inc. · Dental device
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Jan 1978
Decision
197d
Days
Class 2
Risk

K771114 is an FDA 510(k) clearance for the NEUTROCIM. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Septodont, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 4, 1978 after a review of 197 days - an extended review 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: 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 Septodont, Inc. devices

FDA 510(k) Submission Details - K771114

510(k) Number K771114 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 1977
Decision Date January 04, 1978
Days to Decision 197 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
69d slower than avg
Panel avg: 128d · This submission: 197d
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 440
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K771114.
KETAC APPLIC-CAPSULES
K790832 · Espe GmbH (Us) · Apr 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
SCUTABOND
K771451 · Premier Dental Products Co. · Aug 1977
ESPETEMP (TEMP. CEMENT)
K770923 · Espe GmbH (Us) · Jun 1977