Search Results

Found 2 results

510(k) Data Aggregation

K Number

K132109

Device Name

ENAMELAST

Manufacturer

ULTRADENT PRODUCTS INC. / ORATECH LLC

Date Cleared

2013-11-01

(116 days)

Product Code

LBH

Regulation Number

872.3260

Intended Use

Enamelast™ Fluoride Varnish is 5% sodium fluoride in a varnish carrier which produces a mechanical occlusion of the dentinal tubules in the treatment of tooth hypersensitivity.

Device Description

Enamelast Fluoride Varnish is a flavored, xylitol-sweetened 5% sodium fluoride in a resin carrier delivered in a 0.4mL unit dose blister pack or in a 1.2mL syringe. Applicator brushes are provided with the 0.4mL unit dose blister. Delivery mechanisms are recommended in the instructions for use.

Ask a Question

K Number

K132255

Device Name

ULTRACEM

Manufacturer

ULTRADENT PRODUCTS INC. / ORATECH LLC

Date Cleared

2013-10-24

(97 days)

Product Code

EMA

Regulation Number

872.3275

Intended Use

UltraCem™ is indicated for cementation of indirect restorations (including inlays, onlays, crowns and bridges) made of metal, porcelain fused to metal, zirconia, and resin to natural teeth. This product is also intended for cementation of orthodontic bands to natural teeth.

Device Description

UltraCem™ is a chemical cure, resin reinforced (modified) glass ionomer cement. UltraCem™ is supplied in a pre-mixed syringe for easy delivery and no waste, and also in two part bottles to be mixed with application brushes then directly applied to surfaces.

Ask a Question

Page 1 of 1