MASTER-DENT

Primary DI
00816526020565
Brand
MASTER-DENT
Company
DENTONICS INC
Model
15-500
Device description
Glass Ionomer Light Cure Resin Reinforced Restorative, (15 gm Powder/7 ml Liquid)
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K895386000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K895386000GLASIONScientific Pharmaceuticals, Inc.1990-04-16EMA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816526020565PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816526020565008165260205658165260205650816526020565

GMDN Terms#

Term, Definition table
TermDefinition
Endodontic filling/sealing materialA prefabricated, solid dental substance used in endodontics to fill or permanently obturate the root canal of a tooth. The substance may set without assistance of moisture, and is typically intended for orthograde use (i.e., a root filling placed from the coronal aspect). The device has various metallic or polymeric compositions that include, but are not limited to, silver (Ag), methylmethacrylate, zinc oxide eugenol, glass alkenoate, and calcium hydroxide (Ca(OH)2). This GMDN code does not include gutta-percha. After application, this device cannot be reused.

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