MDC Dental

GUDID 07506338300810

Tone A 3.5. Box wit: 2 10:1 cartridge with 70g (50 ml) + 10 mixing tips + instructions. It is used in the elaboration of all kinds of temporary dental Provisionals: inlays, onlays, veneers, bridges and partial or total crowns. It can be used as a filling / relining material for precast and temporary composite and metal crowns.

MDC DENTAL

Temporary dental crown/bridge Temporary dental crown/bridge Temporary dental crown/bridge Temporary dental crown/bridge Temporary dental crown/bridge Temporary dental crown/bridge Temporary dental crown/bridge Temporary dental crown/bridge Temporary dental crown/bridge Temporary dental crown/bridge Temporary dental crown/bridge Temporary dental crown/bridge Temporary dental crown/bridge Temporary dental crown/bridge Temporary dental crown/bridge

• Primary Device ID: 07506338300810
• NIH Device Record Key: 20a0508a-2725-48f1-87e2-eab8dbb8a68b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MDC Dental
• Version Model Number: Bisacryl Nictone A 3.5 Tone
• Company DUNS: 811180298
• Company Name: MDC DENTAL
• 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: false
• Device Combination Product: false
• Single Use: true
• 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: true

Customer Support Contacts

• Phone: +523338330333
• Email: coordrsa@dental.com.mx
• Phone: +523338330333
• Email: coordrsa@dental.com.mx
• Phone: +523338330333
• Email: coordrsa@dental.com.mx
• Phone: +523338330333
• Email: coordrsa@dental.com.mx
• Phone: +523338330333
• Email: coordrsa@dental.com.mx
• Phone: +523338330333
• Email: coordrsa@dental.com.mx
• Phone: +523338330333
• Email: coordrsa@dental.com.mx
• Phone: +523338330333
• Email: coordrsa@dental.com.mx
• Phone: +523338330333
• Email: coordrsa@dental.com.mx
• Phone: +523338330333
• Email: coordrsa@dental.com.mx
• Phone: +523338330333
• Email: coordrsa@dental.com.mx
• Phone: +523338330333
• Email: coordrsa@dental.com.mx
• Phone: +523338330333
• Email: coordrsa@dental.com.mx
• Phone: +523338330333
• Email: coordrsa@dental.com.mx
• Phone: +523338330333
• Email: coordrsa@dental.com.mx

Operating and Storage Conditions

• Storage Environment Temperature: Between 23 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 23 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 23 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 23 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 23 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 23 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 23 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 23 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 23 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 23 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 23 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 23 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 23 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 23 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 23 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07506338300810 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K991577

FDA Product Code

• EBG: Crown And Bridge, Temporary, Resin

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-11-10
• Device Publish Date: 2021-11-02

On-Brand Devices [MDC Dental]

• 07506338300353: Tone A1. Box with: 1 10: 1 cartridge with 70 g (50 ml) + 10 mixing tips + instructions. It is us
• 07506338300728: Tone A1. Box with: 2 10:1 cartridge with 70 g (50 ml) + 20 mixing tips + instructions. It is use
• 07506338300759: Tone A2. Box wit: 2 10:1 cartridge with 70g (50 ml) + 20 mixing tips + instructions + dispenser
• 07506338300742: Tone A2. Box wit: 2 10:1 cartridge with 70g (50 ml) + 20 mixing tips + instructions. It is used
• 07506338300735: Tone A1. Box wit: 2 10:1 cartridge with 70g (50 ml) + 20 mixing tips + instructions + dispenser
• 07506338300377: Tone A3. Box wit: 1 10:1 cartridge with 70g (50 ml) + 10 mixing tips + instructions. It is used
• 07506338300360: Tone A2. Box wit: 1 10:1 cartridge with 70g (50 ml) + 10 mixing tips + instructions. It is used
• 07506338300780: Tone A3.5 Box wit: 1 10:1 cartridge with 70g (50 ml) + 10 mixing tips + instructions. It is used
• 07506338300773: Tone A3. Box wit: 2 10:1 cartridge with 70g (50 ml) + 20 mixing tips + instructions + dispenser
• 07506338300766: Tone A3. Box wit: 2 10:1 cartridge with 70g (50 ml) + 20 mixing tips + instructions. It is used
• 07506338300865: Tone B1. Box wit: 2 10:1 cartridge with 70g (50 ml) + 20 mixing tips + instructions + dispenser
• 07506338300858: Tone B1. Box wit: 2 10:1 cartridge with 70g (50 ml) + 20 mixing tips + instructions. It is used
• 07506338300841: Tone B1. Box wit: 1 10:1 cartridge with 70g (50 ml) + 10 mixing tips + instructions. It is used
• 07506338300834: Tone A4. Box wit: 2 10:1 cartridge with 70g (50 ml) + 20 mixing tips + instructions + dispenser
• 07506338300827: Tone A4. Box wit: 2 10:1 cartridge with 70g (50 ml) + 20 mixing tips + instructions. It is used
• 07506338300889: Tone B2 Box wit: 2 10:1 cartridge with 70g (50 ml) + 20 mixing tips + instructions. It is used i
• 07506338300872: Tone B2. Box wit: 1 10:1 cartridge with 70g (50 ml) + 10 mixing tips + instructions. It is used
• 07506338300810: Tone A 3.5. Box wit: 2 10:1 cartridge with 70g (50 ml) + 10 mixing tips + instructions. It is us
• 07506338300803: Tone A 3.5. Box wit: 2 10:1 cartridge with 70g (50 ml) + 20 mixing tips + instructions + dispens
• 07506338300797: Tone A 3.5. Box wit: 2 10:1 cartridge with 70g (50 ml) + 20 mixing tips + instructions. It is us
• 07506338300957: Tone C1. Box wit: 1 10:1 cartridge with 70g (50 ml) + 10 mixing tips + instructions. It is used
• 07506338300940: Tone BL. Box wit: 2 10:1 cartridge with 70g (50 ml) + 20 mixing tips + instructions + dispenser
• 07506338300933: Tone BL. Box wit: 2 10:1 cartridge with 70g (50 ml) + 20 mixing tips + instructions. It is used
• 07506338300926: Tone B3. Box wit: 2 10:1 cartridge with 70g (50 ml) + 20 mixing tips + instructions + dispenser
• 07506338300919: Tone B3. Box wit: 2 10:1 cartridge with 70g (50 ml) + 20 mixing tips + instructions. It is used
• 07506338300902: Tone B3. Box wit: 1 10:1 cartridge with 70g (50 ml) + 10 mixing tips + instructions. It is used
• 07506338300896: Tone B2. Box wit: 2 10:1 cartridge with 70g (50 ml) + 20 mixing tips + instructions + dispenser
• 07506338300322: Tone BL. Box wit: 2 10:1 cartridge with 70g (50 ml) + 20 mixing tips + instructions + dispenser
• 07506338300971: Tone C1. Box wit: 2 10:1 cartridge with 70g (50 ml) + 20 mixing tips + instructions + dispenser
• 07506338300964: Tone C1. Box wit: 2 10:1 cartridge with 70g (50 ml) + 20 mixing tips + instructions. It is used
• 07506338301008: Tone C2. Box wit: 2 10:1 cartridge with 70g (50 ml) + 20 mixing tips + instructions + dispenser
• 07506338300995: Tone C2. Box wit: 2 10:1 cartridge with 70g (50 ml) + 20 mixing tips + instructions. It is used
• 07506338300988: Tone C2. Box wit: 1 10:1 cartridge with 70g (50 ml) + 10 mixing tips + instructions. It is used
• 07506338301060: Type II normal setting alginate Metallic bag with 454 gr Removable and skeletal prostheses. Impr
• 07506338301053: Metallic bag with 454 gr and plastic bottle To take dental impressions in which fine details can
• 07506338301046: Type I fast-setting and Type II normal-setting. 21g bag To take dental impressions in which fine
• 07506338301039: Type I fast-setting and Type II normal-setting. 454g bag To take dental impressions in which fin
• 07506338301022: Box with 21g 20 bags. To take dental impressions in which fine details can be reproduced, existi
• 07506338301015: 454 g Bag To take dental impressions in which fine details can be reproduced, existing in the or
• 07506338300209: Light body/normal set. Polyvinylsiloxane elastomer for making dental impressions.
• 07506338301077: Bid register / fast set. Polyvinylsiloxane elastomer for making dental impressions.
• 07506338300247: Putty / normal set. Polyvinylsiloxane elastomer for making dental impressions.
• 07506338300230: Putty / fast set. Polyvinylsiloxane elastomer for making dental impressions.
• 07506338300223: Light body/normal set. Polyvinylsiloxane elastomer for making dental impressions.
• 07506338300216: Heavy body/normal set. Polyvinylsiloxane elastomer for making dental impressions.
• 07506338300193: Bit register / fast set. Polyvinylsiloxane elastomer for making dental impressions.
• 07506338315104: MAX PRINT ALL PURPOSE TYPE I SAMPLE 21GR
• 07506338315050: MAX PRINT CYAN ALGINATE TYPE II SAMPLE 21GR
• 07506338315029: MAX PRINT CHROMATIC TYPE I SAMPLE 21GR
• 07506338315012: MAX PRINT ALL PURPOSE ALGINATE TYPE II BOX WITH 10 BAGS OF 454GR