FDA.reportPublic FDA data

MASTER-DENT

Primary DI
00816526021746
Brand
MASTER-DENT
Company
DENTONICS INC
Model
20-228
Device description
Vinyl Polysiloxane Cartridges, REGULAR Set, Medium Body (2x50ml cart. w/ mixing tips)
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
ELWMaterial, Impression

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ELWMaterial, ImpressionDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K930248000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K930248000VINYL POLYSILOXANE 2 COMPONENT VULCANIZING SYSTEMCrown Delta Corp.1994-01-07ELW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816526021746PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816526021746008165260217468165260217460816526021746

GMDN Terms#

Term, Definition table
TermDefinition
Dental impression material syringe, reusableA non-sterile hand-held manual dental instrument designed to inject impression material into an impression tray or directly into a patient's mouth. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
704-238-0245sales@dentonics.com

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
18016200021546KROMOPAN SIL putty soft (2x300ml) - NORMAL SETLASCOD SPAELW2026-05-28
18016200021553KROMOPAN SIL putty hard (2x300ml) - NORMAL SETLASCOD SPAELW2026-05-28
18016200021560KROMOPAN SIL superlight body (2x50ml) - NORMAL SETLASCOD SPAELW2026-05-28
18016200021577KROMOPAN SIL superlight body ECONOMY PACK (4x50ml) - NORMAL SETLASCOD SPAELW2026-05-28
18016200021584KROMOPAN SIL light body (2x50ml) - NORMAL SETLASCOD SPAELW2026-05-28
18016200021591KROMOPAN SIL light body ECONOMY PACK (4x50ml) - NORMAL SETLASCOD SPAELW2026-05-28
18016200021607KROMOPAN SIL regular body (2x50ml) - NORMAL SETLASCOD SPAELW2026-05-28
18016200021614KROMOPAN SIL regular body ECONOMY PACK (4x50ml) - NORMAL SETLASCOD SPAELW2026-05-28
18016200021621KROMOPAN SIL heavy body (2x50ml) - NORMAL SETLASCOD SPAELW2026-05-28
18016200021638KROMOPAN SIL heavy body ECONOMY PACK (4x50ml) - NORMAL SETLASCOD SPAELW2026-05-28
18016200021676KROMOPAN SIL putty soft (2x300ml) - FAST SETLASCOD SPAELW2026-05-28
18016200021683KROMOPAN SIL putty hard (2x300ml) - FAST SETLASCOD SPAELW2026-05-28
18016200021690KROMOPAN SIL superlight body (2x50ml) - FAST SETLASCOD SPAELW2026-05-28
18016200021706KROMOPAN SIL superlight body (4x50ml) - FAST SETLASCOD SPAELW2026-05-28
18016200021713KROMOPAN SIL light body (2x50ml) - FAST SETLASCOD SPAELW2026-05-28
18016200021720KROMOPAN SIL light body ECONOMY PACK (4x50ml) - FAST SETLASCOD SPAELW2026-05-28
18016200021737KROMOPAN SIL regular body (2x50ml) - FAST SETLASCOD SPAELW2026-05-28
18016200021744KROMOPAN SIL regular body (4x50ml) - FAST SETLASCOD SPAELW2026-05-28
18016200021751KROMOPAN SIL heavy body (2x50ml) - FAST SETLASCOD SPAELW2026-05-28
18016200021768KROMOPAN SIL heavy body ECONOMY PACK (4x50ml) - FAST SETLASCOD SPAELW2026-05-28
18016200021805KROMOPAN SIL MONO - monofase (2x50ml)LASCOD SPAELW2026-05-28
18016200021843KromopanSil Bite 2x50mlLASCOD SPAELW2026-05-28
18016200010298IQ - alginato non cromatico verde tipo 1 (24x450g)LASCOD SPAELW2026-05-27
18016200010496IQ TROPICAL - alginato cromatico tipo 1 (24x450g)LASCOD SPAELW2026-05-27
18016200010748IQ - alginato chrom viola/lilla/verde tipo 1 (24x450g)LASCOD SPAELW2026-05-27
18016200011318Mono7LASCOD SPAELW2026-05-27
00850079280441HygedentUSAHexa DentalELW2026-01-12
00850079280465HygedentUSAHexa DentalELW2026-01-12
00850079280472HygedentUSAHexa DentalELW2026-01-12
00850079280489HYgedentUSAHexa DentalELW2026-01-12