Cleared Traditional

K910465 - MELIODENT, DENTURE RESIN

K910465 is an FDA 510(k) clearance for MELIODENT, manufactured by Heraeus Kulzer, Inc.. The device is a Class 2 Dental device with product code EBI cleared through the Traditional 510(k) pathway after a 122-day FDA review.

K910465 · Heraeus Kulzer, Inc. · Dental device
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Jun 1991
Decision
122d
Days
Class 2
Risk

K910465 is an FDA 510(k) clearance for the MELIODENT, DENTURE RESIN. Classified as Resin, Denture, Relining, Repairing, Rebasing (product code EBI), Class II - Special Controls.

Submitted by Heraeus Kulzer, Inc. (South Bend, US). The FDA issued a Cleared decision on June 6, 1991 after a review of 122 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3760 - 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 Heraeus Kulzer, Inc. devices

FDA 510(k) Submission Details - K910465

510(k) Number K910465 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 1991
Decision Date June 06, 1991
Days to Decision 122 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
5d faster than avg
Panel avg: 127d · This submission: 122d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBI Device Classification - Class 2, Special Controls

Product Code EBI Resin, Denture, Relining, Repairing, Rebasing
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3760
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 - EBI Resin, Denture, Relining, Repairing, Rebasing

All 260
Devices cleared under the same product code (EBI) and FDA review panel - the closest regulatory comparables to K910465.
PROBASE HOT AND PROBASE COLD
K913655 · Ivoclar North America, Inc. · Oct 1991
ACCELAR 20 ADVANCE RAPID CURE REPAIR MATERIAL
K913698 · Heraeus Kulzer, Inc. · Oct 1991
MODERN MATERIALS ORTHODONTIC RESIN
K913699 · Heraeus Kulzer, Inc. · Oct 1991
NEW TRIAD TRANSHEET DENTURE BASE MATERIAL
K905702 · Dentsply Intl. · Apr 1991
PALAPRESS(R) VARIO RESIN
K902115 · Kulzer, Inc. · Jul 1990
PALADON(R) 65
K901789 · Kulzer, Inc. · Jun 1990