FDA.reportPublic FDA data

MASTER-DENT

Primary DI
00816526022446
Brand
MASTER-DENT
Company
DENTONICS INC
Model
20-005
Device description
MASTER-DENT VPS PUTTY FAST SET (300ml CATALYST/300ml BASE)
Published
2023-10-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
ELWMaterial, Impression

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ELWMaterial, ImpressionDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K801380000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K801380000CROWN DELTA SILICONE IMPRESSION MATERIALCrown Delta Corp.1980-07-08ELW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816526022446PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816526022446008165260224468165260224460816526022446

GMDN Terms#

Term, Definition table
TermDefinition
Silicone dental impression materialAn elastomeric, polysiloxane-based material capable of reacting to form a rubber-like substance suitable to reproduce the structure of a patient's teeth and gums, or other oral anatomy, after being placed on an impression tray and inserted into the mouth. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
186285342
Device count
1
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

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08800024201719Delikit Light Body FSSherpakoreaELW2020-04-29
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