Cleared Traditional

K990650 - CONSEAL F

K990650 is an FDA 510(k) clearance for CONSEAL F, manufactured by Southern Dental Industries, Inc.. The device is a Class 2 Dental device with product code EBC cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K990650 · Southern Dental Industries, Inc. · Dental device
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May 1999
Decision
74d
Days
Class 2
Risk

K990650 is an FDA 510(k) clearance for the CONSEAL F. Classified as Sealant, Pit And Fissure, And Conditioner (product code EBC), Class II - Special Controls.

Submitted by Southern Dental Industries, Inc. (San Francisco, US). The FDA issued a Cleared decision on May 14, 1999 after a review of 74 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3765 - 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 Southern Dental Industries, Inc. devices

FDA 510(k) Submission Details - K990650

510(k) Number K990650 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 1999
Decision Date May 14, 1999
Days to Decision 74 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 127d · This submission: 74d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBC Device Classification - Class 2, Special Controls

Product Code EBC Sealant, Pit And Fissure, And Conditioner
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3765
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 - EBC Sealant, Pit And Fissure, And Conditioner

All 107
Devices cleared under the same product code (EBC) and FDA review panel - the closest regulatory comparables to K990650.
DELTON FS WITH FLUORIDE PIT & FISSURE SEALANT
K991909 · Dentsply Intl. · Aug 1999
LC PIT & FISSURE SEALANT
K991902 · Bosworth Co. · Jul 1999
AMERICAN DENTAL PRODUCTS ETCH-DETECT
K991099 · American Dental Products, Inc. · Jun 1999
HYDRO-CAST DENTAL ETCHING GEL, MODEL 60025
K990306 · Kay See Dental Mfg. Co. · Mar 1999
DELTON FS DIRECT DELIVERY SYSTEM
K982564 · Dentsply Intl. · Oct 1998
MEDENTAL CHEMICAL CURING SEALANT PIT & FISSURE TINTED
K973541 · Medental Intl. · Nov 1997