Cleared Traditional

K884865 - PERMASEAL AND DENTURE SEAL

K884865 is an FDA 510(k) clearance for PERMASEAL AND DENTURE SEAL, manufactured by American Mfg., Inc.. The device is a Class 2 Dental device with product code EBI cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K884865 · American Mfg., Inc. · Dental device
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Jan 1989
Decision
69d
Days
Class 2
Risk

K884865 is an FDA 510(k) clearance for the PERMASEAL AND DENTURE SEAL. Classified as Resin, Denture, Relining, Repairing, Rebasing (product code EBI), Class II - Special Controls.

Submitted by American Mfg., Inc. (Silver Spring, US). The FDA issued a Cleared decision on January 30, 1989 after a review of 69 days - a notably fast clearance cycle.

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: 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 American Mfg., Inc. devices

FDA 510(k) Submission Details - K884865

510(k) Number K884865 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 1988
Decision Date January 30, 1989
Days to Decision 69 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 128d · This submission: 69d
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 265
Devices cleared under the same product code (EBI) and FDA review panel - the closest regulatory comparables to K884865.
RELIANCE LIGHT CURE RETAINER ACRYLIC
K894564 · Reliance Orthodontic Products, Inc. · Oct 1989
PALASEAL(R)
K892452 · Kulzer, Inc. · Jun 1989
DENTURE RESIN
K890830 · G-C Intl. Corp. · May 1989
BASE, DENTURE, RELINING, REPAIRING, REBASING,RESIN
K883799 · Austenal Dental, Inc. · Oct 1988
TRIAD ORTHODONTIC GEL
K882482 · Dentsply Intl. · Aug 1988
LIGHT CURE DENTURE GLAZE
K871849 · Austenal Dental, Inc. · Aug 1987