Cleared Traditional

K991687 - MODIFICATION TO LINER II: SOFT RELINE LIQUID

K991687 is an FDA 510(k) clearance for MODIFICATION TO LINER II: SOFT RELINE L..., manufactured by Bosworth Co.. The device is a Class 2 Dental device with product code EBI cleared through the Traditional 510(k) pathway after a 143-day FDA review.

K991687 · Bosworth Co. · Dental device
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Oct 1999
Decision
143d
Days
Class 2
Risk

K991687 is an FDA 510(k) clearance for the MODIFICATION TO LINER II: SOFT RELINE LIQUID. Classified as Resin, Denture, Relining, Repairing, Rebasing (product code EBI), Class II - Special Controls.

Submitted by Bosworth Co. (Skokie, US). The FDA issued a Cleared decision on October 7, 1999 after a review of 143 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 Bosworth Co. devices

FDA 510(k) Submission Details - K991687

510(k) Number K991687 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 1999
Decision Date October 07, 1999
Days to Decision 143 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
16d slower than avg
Panel avg: 127d · This submission: 143d
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 259
Devices cleared under the same product code (EBI) and FDA review panel - the closest regulatory comparables to K991687.
EXCEL ULTRA-HI FORMULA HEAT-CURED DENTURE BASE MATERIAL
K992176 · St. George Technology, Inc. · Feb 2000
UFI GEL HARD
K993827 · Voco GmbH · Jan 2000
ENIGMA HI-BASE DENTURE BASE MATERIAL
K993717 · Davis Schottlander & Davis, Ltd. · Dec 1999
LUCITONE FRS FLEXIBEL DENTAL RESIN
K992956 · Dentsply Intl. · Oct 1999
NIC TONE ACRYLIC RESINS
K991577 · Manufacturera Dental Continental · Sep 1999
HYDRO-CAST SILICONE SOFT-LINER, MODEL 68400
K992609 · Kay See Dental Mfg. Co. · Sep 1999