Ultra-Bond® 031982210

GUDID D8130319822101

TRY-IN B0 SY 4pc KIT

DEN-MAT HOLDINGS, LLC

Dental composite resin
Primary Device IDD8130319822101
NIH Device Record Key689e94ac-acc3-4070-8619-64b66b9039f1
Commercial Distribution StatusIn Commercial Distribution
Brand NameUltra-Bond®
Version Model Number031982210
Catalog Number031982210
Company DUNS809857704
Company NameDEN-MAT HOLDINGS, LLC
Device Count4
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

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Handling Environment TemperatureBetween 33 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment TemperatureBetween 33 Degrees Fahrenheit and 75 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate Ultra-Bond Plus resin cement
Special Storage Condition, SpecifyBetween 0 and 0 *Bring to room temperature prior to use
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Handling Environment TemperatureBetween 33 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment TemperatureBetween 33 Degrees Fahrenheit and 75 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate Ultra-Bond Plus resin cement
Special Storage Condition, SpecifyBetween 0 and 0 *Bring to room temperature prior to use
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Handling Environment TemperatureBetween 33 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment TemperatureBetween 33 Degrees Fahrenheit and 75 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate Ultra-Bond Plus resin cement
Special Storage Condition, SpecifyBetween 0 and 0 *Bring to room temperature prior to use
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Handling Environment TemperatureBetween 33 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment TemperatureBetween 33 Degrees Fahrenheit and 75 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate Ultra-Bond Plus resin cement
Special Storage Condition, SpecifyBetween 0 and 0 *Bring to room temperature prior to use
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Handling Environment TemperatureBetween 33 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment TemperatureBetween 33 Degrees Fahrenheit and 75 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate Ultra-Bond Plus resin cement
Special Storage Condition, SpecifyBetween 0 and 0 *Bring to room temperature prior to use
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Handling Environment TemperatureBetween 33 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment TemperatureBetween 33 Degrees Fahrenheit and 75 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate Ultra-Bond Plus resin cement
Special Storage Condition, SpecifyBetween 0 and 0 *Bring to room temperature prior to use
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Handling Environment TemperatureBetween 33 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment TemperatureBetween 33 Degrees Fahrenheit and 75 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate Ultra-Bond Plus resin cement
Special Storage Condition, SpecifyBetween 0 and 0 *Bring to room temperature prior to use
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Handling Environment TemperatureBetween 33 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment TemperatureBetween 33 Degrees Fahrenheit and 75 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate Ultra-Bond Plus resin cement
Special Storage Condition, SpecifyBetween 0 and 0 *Bring to room temperature prior to use
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Handling Environment TemperatureBetween 33 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment TemperatureBetween 33 Degrees Fahrenheit and 75 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate Ultra-Bond Plus resin cement
Special Storage Condition, SpecifyBetween 0 and 0 *Bring to room temperature prior to use
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Handling Environment TemperatureBetween 33 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment TemperatureBetween 33 Degrees Fahrenheit and 75 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate Ultra-Bond Plus resin cement
Special Storage Condition, SpecifyBetween 0 and 0 *Bring to room temperature prior to use
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Handling Environment TemperatureBetween 33 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment TemperatureBetween 33 Degrees Fahrenheit and 75 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate Ultra-Bond Plus resin cement
Special Storage Condition, SpecifyBetween 0 and 0 *Bring to room temperature prior to use
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Handling Environment TemperatureBetween 33 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment TemperatureBetween 33 Degrees Fahrenheit and 75 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate Ultra-Bond Plus resin cement
Special Storage Condition, SpecifyBetween 0 and 0 *Bring to room temperature prior to use
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Handling Environment TemperatureBetween 33 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment TemperatureBetween 33 Degrees Fahrenheit and 75 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate Ultra-Bond Plus resin cement
Special Storage Condition, SpecifyBetween 0 and 0 *Bring to room temperature prior to use
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Handling Environment TemperatureBetween 33 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment TemperatureBetween 33 Degrees Fahrenheit and 75 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate Ultra-Bond Plus resin cement
Special Storage Condition, SpecifyBetween 0 and 0 *Bring to room temperature prior to use
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Handling Environment TemperatureBetween 33 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment TemperatureBetween 33 Degrees Fahrenheit and 75 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate Ultra-Bond Plus resin cement
Special Storage Condition, SpecifyBetween 0 and 0 *Bring to room temperature prior to use
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Handling Environment TemperatureBetween 33 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment TemperatureBetween 33 Degrees Fahrenheit and 75 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate Ultra-Bond Plus resin cement
Special Storage Condition, SpecifyBetween 0 and 0 *Bring to room temperature prior to use
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD8130319822100 [Unit of Use]
HIBCCD8130319822101 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EMACement, Dental

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-24

On-Brand Devices [Ultra-Bond®]

D813325999500U-BOND PLUS CUSTOM KIT 
D8130325999500U-BOND PLUS CUSTOM KIT 
D8130325997500U-BOND PLUS MULTI SH 6g KIT R1
D8130325993900UB PLUS A2 DC 6g RFL KIT
D8130325993800UB PLUS SUP WHT DC RFL KIT R:1
D8130325993700UB PLUS NEU DC 6g RFL KIT R:1
D8130325993500UB PLUS B0 DC 6g RFL KIT
D8130325993300UB PLUS B1 DC 6g RFL KIT
D8130325993100UB PLUS A1 DC 6g RFL KIT R:1
D8130325991100U-BOND PLUS M/S INTRO KIT
D8130324921100BLOCK OUT UBP M/S INTRO KIT
D8130324915500BLOCK OUT UBP M/S BTO KIT     
D8130324915100BLOCK OUT UBP M/S BONDING KIT
D8130324914100BLOCK OUT UBP SUP WHT KT
D8130324913100BLOCK OUT UBP B0 KIT
D8130324912100BLOCK OUT UBP B1 KIT
D8130324911100BLOCK OUT UBP A1 KIT
D8130319828101TRY-IN SUP WHT SY 4pc KIT
D8130319827101TRY-IN NEUTRAL SY 4pc KIT
D8130319825101TRY-IN A1 SY 4pc KIT
D8130319823101TRY-IN B1 SY 4pc KIT
D8130319822101TRY-IN B0 SY 4pc KIT
D8130313435500TRY-IN MULTI-SHADE PST KIT

Trademark Results [Ultra-Bond]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ULTRA-BOND
ULTRA-BOND
87004513 5049887 Live/Registered
Great American Insurance Company
2016-04-18
ULTRA-BOND
ULTRA-BOND
85687480 4305162 Live/Registered
P.F.I., Inc.
2012-07-26
ULTRA-BOND
ULTRA-BOND
75376128 2574812 Live/Registered
SWIMC LLC
1997-10-20
ULTRA-BOND
ULTRA-BOND
74325454 1795026 Live/Registered
GREIF INTERNATIONAL HOLDING B.V.
1992-10-26
ULTRA-BOND
ULTRA-BOND
73416681 1310732 Live/Registered
Den-Mat, Inc.
1983-03-10
ULTRA-BOND
ULTRA-BOND
73105855 1079623 Live/Registered
RFR CORP.
1976-11-08

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