MASTER-DENT 19-000-B

GUDID 00816526021135

Core Build-Up, Paste-Paste, 14gm Base Paste & 14gm Catalyst Paste, Blue

DENTONICS INC

Dental composite resin

• Primary Device ID: 00816526021135
• NIH Device Record Key: ae3b6ea2-8502-44a5-a9dd-3fcd4cd5cc5b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MASTER-DENT
• Version Model Number: 19-000-B
• Catalog Number: 19-000-B
• Company DUNS: 186285342
• Company Name: DENTONICS INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 704-238-0245
• Email: sales@dentonics.com
• Phone: 704-238-0245
• Email: sales@dentonics.com
• Phone: 704-238-0245
• Email: sales@dentonics.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816526021135 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K832781

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-16

On-Brand Devices [MASTER-DENT ]

• 00816526022057: Vinyl Polysiloxane Cartridges, REGULAR Set, Monophase, 2 X 50 ml cartridge with Mixing Tips
• 00816526022040: Vinyl Polysiloxane Cartridges, FAST Set, Heavy Body , 1 X 380 ml cartridge, 1 Bayonet Ring, 10 D
• 00816526022033: Vinyl Polysiloxane Cartridges, REGULAR Set, Heavy Body , 1 X 380 ml cartridge, 1 Bayonet Ring, 1
• 00816526022026: Vinyl Polysiloxane Cartridges Refill Kit, FAST Set, Heavy Body, 2 X 380 ml cartridge
• 00816526022019: Vinyl Polysiloxane Cartridges Refill Kit, REGULAR Set, Heavy Body, 2 X 380 ml cartridge
• 00816526022002: Vinyl Polysiloxane Cartridges, FAST Set, Alginate Alternate, 1 X 380 ml cartridge, 1 Bayonet Rin
• 00816526021999: Vinyl Polysiloxane Cartridges, REGULAR Set, Alginate Alternate, 1 X 380 ml cartridge, 1 Bayonet
• 00816526021982: Vinyl Polysiloxane Cartridges, Refill Kit , , FAST Set, Alginate Alternate, 2 X 380 ml cartridge
• 00816526021975: Vinyl Polysiloxane Cartridges, Refill Kit , REGULAR Set, Alginate Alternate, 2 X 380 ml cartridg
• 00816526021968: Vinyl Polysiloxane Cartridges, FAST Set, Monophase, 1 X 380 ml cartridge, 1 Bayonet Ring, 10 Dyn
• 00816526021951: Vinyl Polysiloxane Cartridges, REGULAR Set, Monophase , 1 X 380 ml cartridge, 1 Bayonet Ring, 10
• 00816526021944: Vinyl Polysiloxane Cartridges, Refill Kit , FAST Set, Monophase, 2 X 380 ml cartridge
• 00816526021937: Vinyl Polysiloxane Cartridges, Refill Kit , REGULAR Set, Monophase , 2 X 380 ml cartridge
• 00816526021920: EDTA Solution, 17% 8 oz bottle
• 00816526021913: EDTA Solution, 17% 2 oz bottle
• 00816526021852: Bite Registration, Fast Set HP, (2x50ml Cartridges w/ tips)
• 00816526021845: Bite Registration, Fast Set HP, (1 x 50ml Cartridge)
• 00816526021838: Bite Registration, Regular Set HP, (2x50ml Cartridges w/ tips)
• 00816526021821: Bite Registration, Regular Set HP, ( 1 x 50ml Cartridge)
• 00816526021814: Vinyl Polysiloxane Cartridges, FAST Set, Heavy Body (4x50ml cart. w/ mixing tips)
• 00816526021807: Vinyl Polysiloxane Cartridges, FAST Set, Heavy Body (2x50ml cart. only)
• 00816526021791: Vinyl Polysiloxane Cartridges, REGULAR Set, Heavy Body (4x50ml cart. only)
• 00816526021784: Vinyl Polysiloxane Cartridges, REGULAR Set, Heavy Body (2x50ml cart. w/ mixing tips)
• 00816526021777: Vinyl Polysiloxane Cartridges, FAST Set, Medium Body (4x50ml cart. only)
• 00816526021760: Vinyl Polysiloxane Cartridges, FAST Set, Medium Body (2x50ml cart. w/ mixing tips)
• 00816526021753: Vinyl Polysiloxane Cartridges, REGULAR Set, Medium Body (4x50ml cart. only)
• 00816526021746: Vinyl Polysiloxane Cartridges, REGULAR Set, Medium Body (2x50ml cart. w/ mixing tips)
• 00816526021739: Vinyl Polysiloxane Cartridges, FAST Set, Light Body (4x50ml cart. only)
• 00816526021722: Vinyl Polysiloxane Cartridges, FAST Set, Light Body (2x50ml cart. w/ mixing tips)
• 00816526021715: Vinyl Polysiloxane Cartridges, REGULAR Set, Light Body (4x50ml cart. only)
• 00816526021708: Vinyl Polysiloxane Cartridges, REGULAR Set, Light Body (2x50ml cart. w/ mixing tips)
• 00816526021692: Vinyl Polysiloxane Putty, 2 putty jars (600ml Catalyst & 600ml Base) (1200 ml total) & 2 scoops
• 00816526021685: Vinyl Polysiloxane Putty, 2 putty jars (300ml Catalyst & 300ml Base) (600 ml total) & 2 scoops
• 00816526021678: No-Mix Adhesive Kit, 3 X 5 gm syringe, 16 ml Primer, 9 gm Etch
• 00816526021661: No-Mix Adhesive Primer, 6 ml bottle
• 00816526021654: Light Cure, Orthodontic Bracket Adhesive, 4 X 5 gm Syringes, 7 gm Primer, 15 ml Etch
• 00816526021647: Light Cure, Orthodontic Adhesive Primer 7 gm bottle
• 00816526021630: Light Cure, Orthodontic Adhesive Paste, 5 gm syringe
• 00816526021623: Root Canal Sealer Kit, 6 ml liquid
• 00816526021616: Master-Fil NANO, 20 x 0.25 gm Compules, Shade B1
• 00816526021609: Master-Fil NANO, 4.5gm Syringe, Shade B1
• 00816526021593: Master-Fil MICRO 20 x 0.25 gm Compules (B1 Shade)
• 00816526021586: MASTER-FLOW, 2x2gm Syringes, (Opaque Shade) w/ Tips, pouch
• 00816526021579: MASTER-FLOW, 2x2gm Syringes, (Gingival Shade) w/ Tips, pouch
• 00816526021562: MASTER-FLOW, 2x2gm Syringes, (D3 Shade) w/ Tips, pouch
• 00816526021555: MASTER-FLOW, 2x2gm Syringes, (C3 Shade) w/ Tips, pouch
• 00816526021548: MASTER-FLOW, 2x2gm Syringes, (C1 Shade) w/ Tips, pouch
• 00816526021531: MASTER-FLOW, 2x2gm Syringes, (B2 Shade) w/ Tips, pouch
• 00816526021524: MASTER-FLOW, 2x2gm Syringes, (B1 Shade) w/ Tips, pouch
• 00816526021517: MASTER-FLOW, 2x2gm Syringes, (A4 Shade) w/ Tips, pouch