Cleared Traditional

K850913 - GLAS IONOMER CEMENT

K850913 is an FDA 510(k) clearance for GLAS IONOMER CEMENT, manufactured by Shofu Dental Corp.. The device is a Class 2 Dental device with product code EMA cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K850913 · Shofu Dental Corp. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1985
Decision
36d
Days
Class 2
Risk

K850913 is an FDA 510(k) clearance for the GLAS IONOMER CEMENT. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Shofu Dental Corp. (Menlo Park, US). The FDA issued a Cleared decision on April 10, 1985 after a review of 36 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 Shofu Dental Corp. devices

FDA 510(k) Submission Details - K850913

510(k) Number K850913 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 1985
Decision Date April 10, 1985
Days to Decision 36 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
91d faster than avg
Panel avg: 127d · This submission: 36d
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 396
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K850913.
PANAVIA EX, A DENTAL ADHESIVE
K855211 · Kuraray Co. · Mar 1986
ZIONOMER CEMENT
K852196 · Den-Mat Corp. · Jun 1985
76 EMA LINING CEMENT
K851468 · G-C Intl. Corp. · May 1985
ESPE KETAC-CEM RADIOPAQUE
K844846 · Espe GmbH (Us) · Mar 1985
KETAC-SILVER
K843566 · Espe GmbH (Us) · Dec 1984
KERR RESIN BONDED BRIDGE CEMENT
K840407 · Sybron Corp. · May 1984