UNIFAST™ 339113
GUDID 20386040001196
UNIFAST™ Trad Pink X, 250g powder
Gc America Inc.
Temporary dental crown/bridge resin| Primary Device ID | 20386040001196 |
| NIH Device Record Key | 360d4a96-bfdb-4400-a87f-746706b9e9eb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | UNIFAST™ |
| Version Model Number | 339113 |
| Catalog Number | 339113 |
| 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 |
| customerservice@gcamerica.com | |
| Phone | +1(708)597-0900 |
| customerservice@gcamerica.com | |
| Phone | +1(708)597-0900 |
| customerservice@gcamerica.com | |
| Phone | +1(708)597-0900 |
| customerservice@gcamerica.com | |
| Phone | +1(708)597-0900 |
| customerservice@gcamerica.com | |
| Phone | +1(708)597-0900 |
| customerservice@gcamerica.com | |
| Phone | +1(708)597-0900 |
| customerservice@gcamerica.com | |
| Phone | +1(708)597-0900 |
| customerservice@gcamerica.com | |
| Phone | +1(708)597-0900 |
| customerservice@gcamerica.com |
Device Dimensions
| Weight | 250 Gram |
| Weight | 250 Gram |
| Weight | 250 Gram |
| Weight | 250 Gram |
| Weight | 250 Gram |
| Weight | 250 Gram |
| Weight | 250 Gram |
| Weight | 250 Gram |
| Weight | 250 Gram |
Operating and Storage Conditions
| 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 |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10386040001199 [Primary] |
| GS1 | 20386040001196 [Package] Contains: 10386040001199 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 |
Trademark Results [UNIFAST]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 UNIFAST 76305883 2668427 Dead/Cancelled |
UNIFAST S.r.l. 2001-08-27 |
 UNIFAST 74800972 1777014 Dead/Cancelled |
TEXON USA, INC. 1990-05-10 |
 UNIFAST 74800949 2908871 Dead/Cancelled |
UNITED SHOE MACHINERY CORPORATION 1990-07-05 |
 UNIFAST 74574137 not registered Dead/Abandoned |
Universal Supply & Tool, Inc. 1994-09-15 |
 UNIFAST 74075389 not registered Dead/Abandoned |
UNITED SHOE MACHINERY CORPORATION 1990-07-05 |
 UNIFAST 74057770 1649865 Dead/Cancelled |
United Shoe Machinery Corporation 1990-05-10 |
 UNIFAST 74057568 not registered Dead/Abandoned |
United Shoe Machinery Corporation 1990-05-10 |
 UNIFAST 73384572 not registered Dead/Abandoned |
NPI NEW PRODUCTS INVESTMENT AB 1982-09-10 |
 UNIFAST 73236480 1158751 Dead/Cancelled |
Reid-Provident Laboratories, Inc. 1979-10-24 |
 UNIFAST 73076036 1060341 Dead/Cancelled |
United Piece Dye Works, The 1976-02-02 |
 UNIFAST 71537751 0513502 Dead/Expired |
UNITED PIECE DYE WORKS, THE 1947-10-13 |
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