FDA.reportPublic FDA data

MASTER-DENT

Primary DI
00816526021388
Brand
MASTER-DENT
Company
DENTONICS INC
Model
11-200
Catalog number
11-200
Device description
Light Cure Cavity Liner w/ Fluoride 8 gm syringe
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K860633000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K860633000FLUOROSEAL, DENTIN SEALER AND CAVITY LINERScientific Pharmaceuticals, Inc.1986-04-11LBH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816526021388PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816526021388008165260213888165260213880816526021388

GMDN Terms#

Term, Definition table
TermDefinition
Dental pulp-capping materialA dental compound designed to cover an exposed or nearly-exposed dental pulp (e.g., due to deep cavities) to provide protection against external influences and to promote healing. This compound does not have dental cement or dental cavity liner intended uses. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
186285342
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816526020404MASTER-DENT18-1002016-09-16
00816526020411MASTER-DENT18-1142016-09-16
00816526020428MASTER-DENT18-1052016-09-16
00816526020435MASTER-DENT18-1202016-09-16
00816526020442MASTER-DENT18-1252016-09-16
00816526020459MASTER-DENT18-1302016-09-16
00816526020466MASTER-DENT18-400-L2016-09-16
00816526020473MASTER-DENT18-500-L2016-09-16
00816526020480MASTER-DENT18-600-L2016-09-16
00816526020497MASTER-DENT18-650-L2016-09-16
00816526020503MASTER-DENT18-700-L2016-09-16
00816526020510MASTER-DENT18-400-V2016-09-16
00816526020527MASTER-DENT18-500-V2016-09-16
00816526020534MASTER-DENT18-600-V2016-09-16
00816526020541MASTER-DENT18-650-V2016-09-16
00816526020558MASTER-DENT18-700-V2016-09-16
00816526021456MASTER-DENT18-1242016-09-23
00816526020220MASTER-DENT10-9002023-10-31
00816526020237MASTER-DENT10-9102023-10-31
00816526022422MASTER-DENT32-5102023-10-31