Cleared Traditional

K952121 - 3M RESIN CEMENT

K952121 is an FDA 510(k) clearance for 3M RESIN CEMENT, manufactured by 3M Medical Products Group. The device is a Class 2 Dental device with product code EMA cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K952121 · 3M Medical Products Group · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1995
Decision
48d
Days
Class 2
Risk

K952121 is an FDA 510(k) clearance for the 3M RESIN CEMENT. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by 3M Medical Products Group (St. Paul, US). The FDA issued a Cleared decision on June 22, 1995 after a review of 48 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 3M Medical Products Group devices

FDA 510(k) Submission Details - K952121

510(k) Number K952121 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 1995
Decision Date June 22, 1995
Days to Decision 48 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 127d · This submission: 48d
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 300
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K952121.
PULPDENT DENTASTIC II
K953272 · Pulpdent Corp. · Aug 1995
DENTASTIC ONE-STEP
K953301 · Pulpdent Corp. · Aug 1995
PULPDENT POST CEMENT
K952960 · Pulpdent Corp. · Jul 1995
PULPDENT GLASS IONOMER CEMENTS
K951270 · Pulpdent Corp. · May 1995
FUJI IX
K951555 · GC America, Inc. · May 1995
HI DENSE, GLASS IONOMER SILVER REINFORCED RESTORATIVE
K945451 · Shofu Dental Corp. · Feb 1995