UNIFAST™ 339103

GUDID 20386040000953

UNIFAST™ Trad Pink X, 100g powder

Gc America Inc.

Temporary dental crown/bridge resin

• Primary Device ID: 20386040000953
• NIH Device Record Key: 72e73194-6fa9-4ebe-be32-7e30b64b7577
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UNIFAST™
• Version Model Number: 339103
• Catalog Number: 339103
• Company DUNS: 005473608
• Company Name: Gc America 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: false
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com

Device Dimensions

• Weight: 100 Gram
• Weight: 100 Gram
• Weight: 100 Gram
• Weight: 100 Gram
• Weight: 100 Gram
• Weight: 100 Gram
• Weight: 100 Gram
• Weight: 100 Gram
• Weight: 100 Gram

Operating and Storage Conditions

• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10386040000956 [Primary]
GS1	20386040000953 [Package]; Contains: 10386040000956; Package: Carton [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K984365

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: 2022-07-15
• Device Publish Date: 2022-07-07

On-Brand Devices [UNIFAST™]

• D6583392922: UNIFAST™ Trad 260mL liquid
• D6583392912: UNIFAST™ Trad 104mL liquid
• D6583391251: UNIFAST™ Trad 8 Live Pink, 1kg powder
• D6583391241: UNIFAST™ Trad Ivory, 1kg powder
• D6583391231: UNIFAST™ Trad Pink X, 1kg powder
• D6583391152: UNIFAST™ Trad 8 Live Pink, 250g powder
• D6583391142: UNIFAST™ Trad Ivory, 250g powder
• D6583391132: UNIFAST™ Trad Pink X, 250g powder
• D6583391052: UNIFAST™ Trad 8 Live Pink,100g powder
• D6583391042: UNIFAST™ Trad Ivory, 100g powder
• D6583391032: UNIFAST™ Trad Pink X, 100g powder
• D6583391022: UNIFAST™ Trad 3 Pink, 100g powder
• D6583382032: UNIFAST™ LC Translucent, 50g powder
• D6583381222: UNIFAST™ LC C2, 50g powder
• D6583381132: UNIFAST™ LC B3, 50g powder
• D6583381122: UNIFAST™ LC B2, 50g powder
• D6583381032: UNIFAST™ LC A3, 50g powder
• D6583381022: UNIFAST™ LC A2, 50g powder
• D6583380221: UNIFAST™ LC Package contains 1 bottle Powder (30g) shade C2, 2 bottles Liquid (15mL each), 2 r
• D6583380211: UNIFAST™ LC Package contains 1 bottle Powder (30g) shade Translucent, 2 bottles Liquid (15mL e
• D6583380131: UNIFAST™ LC Package contains 1 bottle Powder (30g) shade B3, 2 bottles Liquid (15mL each), 2 r
• D6583380121: UNIFAST™ LC Package contains 1 bottle Powder (30g) shade B2, 2 bottles Liquid (15mL each), 2 r
• D6583380061: UNIFAST™ LC Intro Package, 6-2 Pack (6 x 30g powder, 2 x 14.7mL liquid)
• D6583380031: UNIFAST™ LC Package contains 1 bottle Powder (30g) shade A3, 2 bottles Liquid (15mL each), 2
• D6583380021: UNIFAST™ LC Package contains 1 bottle Powder (30g) shade A2, 2 bottles Liquid (15mL each), 2 r
• D0470003682: UNIFAST™LC 2 x 14.7 mL liquid btl
• 20386040006696: UNIFAST™ Trad 3 Pink, 100g powder
• 20386040006672: UNIFAST™ LC Translucent, 50g powder
• 20386040006665: UNIFAST™ LC C2, 50g powder
• 20386040006658: UNIFAST™ LC B3, 50g powder
• 20386040006641: UNIFAST™ LC B2, 50g powder
• 20386040006634: UNIFAST™ LC A3, 50g powder
• 20386040006627: UNIFAST™ LC A2, 50g powder
• 10386040006613: UNIFAST™ LC Package contains 1 bottle Powder (30g) shade C2, 2 bottles Liquid (15mL each), 2 r
• 10386040006606: UNIFAST™ LC Package contains 1 bottle Powder (30g) shade Translucent, 2 bottles Liquid (15mL e
• 10386040006590: UNIFAST™ LC Package contains 1 bottle Powder (30g) shade B3, 2 bottles Liquid (15mL each), 2 r
• 10386040006583: UNIFAST™ LC Package contains 1 bottle Powder (30g) shade B2, 2 bottles Liquid (15mL each), 2 r
• 10386040006576: UNIFAST™ LC Package contains 1 bottle Powder (30g) shade A3, 2 bottles Liquid (15mL each), 2
• 10386040006569: UNIFAST™ LC Package contains 1 bottle Powder (30g) shade A2, 2 bottles Liquid (15mL each), 2 r
• 20386040001196: UNIFAST™ Trad Pink X, 250g powder
• 20386040001189: UNIFAST™ Trad 8 Live Pink, 250g powder
• 10386040001175: UNIFAST™ Trad Pink X, 1kg powder
• 10386040001168: UNIFAST™ Trad 8 Live Pink, 1kg powder
• 10386040001151: UNIFAST™ Trad Ivory, 1kg powder
• 20386040001141: UNIFAST™ Trad 8 Live Pink,100g powder
• 10386040001137: UNIFAST™ LC Intro Package, 6-2 Pack (6 x 30g powder, 2 x 14.7mL liquid)
• 20386040000991: UNIFAST™ Trad 260mL liquid
• 20386040000984: UNIFAST™ Trad 104mL liquid
• 20386040000977: UNIFAST™ Trad Ivory, 250g powder
• 20386040000960: UNIFAST™ Trad Ivory, 100g powder