Cleared Traditional

K082115 - PHOGLASS FILL

K082115 is an FDA 510(k) clearance for PHOGLASS FILL, manufactured by S & C Polymer GmbH. The device is a Class 2 Dental device with product code EMA cleared through the Traditional 510(k) pathway after a 171-day FDA review.

K082115 · S & C Polymer GmbH · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2009
Decision
171d
Days
Class 2
Risk

K082115 is an FDA 510(k) clearance for the PHOGLASS FILL, CORE, CEM, SEAL, PRIME AND PHOGLASS PROTECT. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by S & C Polymer GmbH (Elmshorn, DE). The FDA issued a Cleared decision on January 15, 2009 after a review of 171 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 S & C Polymer GmbH devices

FDA 510(k) Submission Details - K082115

510(k) Number K082115 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 2008
Decision Date January 15, 2009
Days to Decision 171 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
44d slower than avg
Panel avg: 127d · This submission: 171d
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 344
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K082115.
SPEEDCEM
K091019 · Ivoclar Vivadent, Inc. · Jun 2009
PHOGLASS CEM
K083766 · S & C Polymer GmbH · Mar 2009
BIFIX SE
K083438 · Voco GmbH · Feb 2009
BISCEM TRANSLUCENT, MODEL D-45011
K082449 · Bisco, Inc. · Sep 2008
CARBOXYLATE CEM, PHOSPHATE CEM
K081702 · S & C Polymer GmbH · Sep 2008
METACEM, META P&BOND, METACEM SILANE CERAMIC PRIMER
K081913 · Meta Biomed Co., Ltd. · Sep 2008