UNIFAST™ 000368

GUDID D0470003682

UNIFAST™LC 2 x 14.7 mL liquid btl

Gc America Inc.

Temporary dental crown/bridge resin
Primary Device IDD0470003682
NIH Device Record Key5cbc5ae8-b5db-4f3d-88d5-787f4bc2a304
Commercial Distribution StatusIn Commercial Distribution
Brand NameUNIFAST™
Version Model Number000368
Catalog Number000368
Company DUNS005473608
Company NameGc America Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com
Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com
Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com
Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com
Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com
Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com
Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com
Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com
Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com
Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com
Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com
Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com
Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com
Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com
Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com
Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com

Device Dimensions

Total Volume14.7 Milliliter
Total Volume14.7 Milliliter
Total Volume14.7 Milliliter
Total Volume14.7 Milliliter
Total Volume14.7 Milliliter
Total Volume14.7 Milliliter
Total Volume14.7 Milliliter
Total Volume14.7 Milliliter
Total Volume14.7 Milliliter
Total Volume14.7 Milliliter
Total Volume14.7 Milliliter
Total Volume14.7 Milliliter
Total Volume14.7 Milliliter
Total Volume14.7 Milliliter
Total Volume14.7 Milliliter
Total Volume14.7 Milliliter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD0470003681 [Primary]
HIBCCD0470003682 [Package]
Contains: D0470003681
Package: Carton [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EBGCROWN AND BRIDGE, TEMPORARY, RESIN

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2021-10-29
Device Publish Date2016-08-01

On-Brand Devices [UNIFAST™]

D6583392922UNIFAST™ Trad 260mL liquid
D6583392912UNIFAST™ Trad 104mL liquid
D6583391251UNIFAST™ Trad 8 Live Pink, 1kg powder
D6583391241UNIFAST™ Trad Ivory, 1kg powder
D6583391231UNIFAST™ Trad Pink X, 1kg powder
D6583391152UNIFAST™ Trad 8 Live Pink, 250g powder
D6583391142UNIFAST™ Trad Ivory, 250g powder
D6583391132UNIFAST™ Trad Pink X, 250g powder
D6583391052UNIFAST™ Trad 8 Live Pink,100g powder
D6583391042UNIFAST™ Trad Ivory, 100g powder
D6583391032UNIFAST™ Trad Pink X, 100g powder
D6583391022UNIFAST™ Trad 3 Pink, 100g powder
D6583382032UNIFAST™ LC Translucent, 50g powder
D6583381222UNIFAST™ LC C2, 50g powder
D6583381132UNIFAST™ LC B3, 50g powder
D6583381122UNIFAST™ LC B2, 50g powder
D6583381032UNIFAST™ LC A3, 50g powder
D6583381022UNIFAST™ LC A2, 50g powder
D6583380221UNIFAST™ LC Package contains 1 bottle Powder (30g) shade C2, 2 bottles Liquid (15mL each), 2 r
D6583380211UNIFAST™ LC Package contains 1 bottle Powder (30g) shade Translucent, 2 bottles Liquid (15mL e
D6583380131UNIFAST™ LC Package contains 1 bottle Powder (30g) shade B3, 2 bottles Liquid (15mL each), 2 r
D6583380121UNIFAST™ LC Package contains 1 bottle Powder (30g) shade B2, 2 bottles Liquid (15mL each), 2 r
D6583380061UNIFAST™ LC Intro Package, 6-2 Pack (6 x 30g powder, 2 x 14.7mL liquid)
D6583380031UNIFAST™ LC Package contains 1 bottle Powder (30g) shade A3, 2 bottles Liquid (15mL each), 2
D6583380021UNIFAST™ LC Package contains 1 bottle Powder (30g) shade A2, 2 bottles Liquid (15mL each), 2 r
D0470003682UNIFAST™LC 2 x 14.7 mL liquid btl
20386040006696UNIFAST™ Trad 3 Pink, 100g powder
20386040006672UNIFAST™ LC Translucent, 50g powder
20386040006665UNIFAST™ LC C2, 50g powder
20386040006658UNIFAST™ LC B3, 50g powder
20386040006641UNIFAST™ LC B2, 50g powder
20386040006634UNIFAST™ LC A3, 50g powder
20386040006627UNIFAST™ LC A2, 50g powder
10386040006613UNIFAST™ LC Package contains 1 bottle Powder (30g) shade C2, 2 bottles Liquid (15mL each), 2 r
10386040006606UNIFAST™ LC Package contains 1 bottle Powder (30g) shade Translucent, 2 bottles Liquid (15mL e
10386040006590UNIFAST™ LC Package contains 1 bottle Powder (30g) shade B3, 2 bottles Liquid (15mL each), 2 r
10386040006583UNIFAST™ LC Package contains 1 bottle Powder (30g) shade B2, 2 bottles Liquid (15mL each), 2 r
10386040006576UNIFAST™ LC Package contains 1 bottle Powder (30g) shade A3, 2 bottles Liquid (15mL each), 2
10386040006569UNIFAST™ LC Package contains 1 bottle Powder (30g) shade A2, 2 bottles Liquid (15mL each), 2 r
20386040001196UNIFAST™ Trad Pink X, 250g powder
20386040001189UNIFAST™ Trad 8 Live Pink, 250g powder
10386040001175UNIFAST™ Trad Pink X, 1kg powder
10386040001168UNIFAST™ Trad 8 Live Pink, 1kg powder
10386040001151UNIFAST™ Trad Ivory, 1kg powder
20386040001141UNIFAST™ Trad 8 Live Pink,100g powder
10386040001137UNIFAST™ LC Intro Package, 6-2 Pack (6 x 30g powder, 2 x 14.7mL liquid)
20386040000991UNIFAST™ Trad 260mL liquid
20386040000984UNIFAST™ Trad 104mL liquid
20386040000977UNIFAST™ Trad Ivory, 250g powder
20386040000960UNIFAST™ Trad Ivory, 100g powder

Trademark Results [UNIFAST]

Mark Image

Registration | Serial
Company
Trademark
Application Date
UNIFAST
UNIFAST
76305883 2668427 Dead/Cancelled
UNIFAST S.r.l.
2001-08-27
UNIFAST
UNIFAST
74800972 1777014 Dead/Cancelled
TEXON USA, INC.
1990-05-10
UNIFAST
UNIFAST
74800949 2908871 Dead/Cancelled
UNITED SHOE MACHINERY CORPORATION
1990-07-05
UNIFAST
UNIFAST
74574137 not registered Dead/Abandoned
Universal Supply & Tool, Inc.
1994-09-15
UNIFAST
UNIFAST
74075389 not registered Dead/Abandoned
UNITED SHOE MACHINERY CORPORATION
1990-07-05
UNIFAST
UNIFAST
74057770 1649865 Dead/Cancelled
United Shoe Machinery Corporation
1990-05-10
UNIFAST
UNIFAST
74057568 not registered Dead/Abandoned
United Shoe Machinery Corporation
1990-05-10
UNIFAST
UNIFAST
73384572 not registered Dead/Abandoned
NPI NEW PRODUCTS INVESTMENT AB
1982-09-10
UNIFAST
UNIFAST
73236480 1158751 Dead/Cancelled
Reid-Provident Laboratories, Inc.
1979-10-24
UNIFAST
UNIFAST
73076036 1060341 Dead/Cancelled
United Piece Dye Works, The
1976-02-02
UNIFAST
UNIFAST
71537751 0513502 Dead/Expired
UNITED PIECE DYE WORKS, THE
1947-10-13
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