SmarTemp® S338

GUDID 00810000525294

Dual Cure A2 (Light Shade) SmarTemp® in 50ml. Cartridge

PARKELL, INC.

Dental crown/bridge resin, temporary Dental crown/bridge resin, temporary Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin
Primary Device ID00810000525294
NIH Device Record Key0f0f060a-7102-4741-b112-1a9015f4cd01
Commercial Distribution StatusIn Commercial Distribution
Brand NameSmarTemp®
Version Model NumberS338
Catalog NumberS338
Company DUNS009900424
Company NamePARKELL, 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

Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 7 Degrees Celsius and 22 Degrees Celsius
Storage Environment TemperatureBetween 7 Degrees Celsius and 22 Degrees Celsius
Storage Environment TemperatureBetween 7 Degrees Celsius and 22 Degrees Celsius
Storage Environment TemperatureBetween 7 Degrees Celsius and 22 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigeration is preferred to prolong shelf-life. However, for optimal setting characteristics, warm to room temperature before use. Avoid sunlight.
Storage Environment TemperatureBetween 7 Degrees Celsius and 22 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigeration is preferred to prolong shelf-life. However, for optimal setting characteristics, warm to room temperature before use. Avoid sunlight.
Storage Environment TemperatureBetween 7 Degrees Celsius and 22 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigeration is preferred to prolong shelf-life. However, for optimal setting characteristics, warm to room temperature before use. Avoid sunlight.
Storage Environment TemperatureBetween 7 Degrees Celsius and 22 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigeration is preferred to prolong shelf-life. However, for optimal setting characteristics, warm to room temperature before use. Avoid sunlight.
Storage Environment TemperatureBetween 7 Degrees Celsius and 22 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigeration is preferred to prolong shelf-life. However, for optimal setting characteristics, warm to room temperature before use. Avoid sunlight.
Storage Environment TemperatureBetween 7 Degrees Celsius and 22 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigeration is preferred to prolong shelf-life. However, for optimal setting characteristics, warm to room temperature before use. Avoid sunlight.
Storage Environment TemperatureBetween 7 Degrees Celsius and 22 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigeration is preferred to prolong shelf-life. However, for optimal setting characteristics, warm to room temperature before use. Avoid sunlight.
Storage Environment TemperatureBetween 7 Degrees Celsius and 22 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigeration is preferred to prolong shelf-life. However, for optimal setting characteristics, warm to room temperature before use. Avoid sunlight.
Storage Environment TemperatureBetween 7 Degrees Celsius and 22 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigeration is preferred to prolong shelf-life. However, for optimal setting characteristics, warm to room temperature before use. Avoid sunlight.
Storage Environment TemperatureBetween 7 Degrees Celsius and 22 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigeration is preferred to prolong shelf-life. However, for optimal setting characteristics, warm to room temperature before use. Avoid sunlight.
Storage Environment TemperatureBetween 7 Degrees Celsius and 22 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigeration is preferred to prolong shelf-life. However, for optimal setting characteristics, warm to room temperature before use. Avoid sunlight.
Storage Environment TemperatureBetween 7 Degrees Celsius and 22 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigeration is preferred to prolong shelf-life. However, for optimal setting characteristics, warm to room temperature before use. Avoid sunlight.
Storage Environment TemperatureBetween 7 Degrees Celsius and 22 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigeration is preferred to prolong shelf-life. However, for optimal setting characteristics, warm to room temperature before use. Avoid sunlight.
Storage Environment TemperatureBetween 7 Degrees Celsius and 22 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigeration is preferred to prolong shelf-life. However, for optimal setting characteristics, warm to room temperature before use. Avoid sunlight.
Storage Environment TemperatureBetween 7 Degrees Celsius and 22 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigeration is preferred to prolong shelf-life. However, for optimal setting characteristics, warm to room temperature before use. Avoid sunlight.
Storage Environment TemperatureBetween 7 Degrees Celsius and 22 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigeration is preferred to prolong shelf-life. However, for optimal setting characteristics, warm to room temperature before use. Avoid sunlight.
Storage Environment TemperatureBetween 7 Degrees Celsius and 22 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100810000525294 [Primary]

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 Number2
Public Version Date2019-09-20
Device Publish Date2018-10-26

On-Brand Devices [SmarTemp®]

00810000525317Medium A3.5 SmarTemp® in 50ml. Cartridge
00810000525300Light A2 SmarTemp® in 50ml. Cartridge
00810000525294Dual Cure A2 (Light Shade) SmarTemp® in 50ml. Cartridge
00810000525287Ultralight A1 SmarTemp® Split 50ml. Cartridge
M595S3410Medium A3.5 SmarTemp® 50ml. Cartridge
M595S3400Light A2 SmarTemp® 50ml. Cartridge
M595S3380Dual Cure A2 (Light Shade) SmarTemp® 50ml. Cartridge
M595S3370Ultralight A1 SmarTemp® Split 50ml. Cartridge
10810000528124SmarTemp® X1 10:1 50ml Mixing Tip Refill (30 pieces)
0081000052813410:1 50ml Split Cartridge Dispensing Gun for SmarTemp® X1
00810000525515SmarTemp® X1 Shade Bleach (50ml 10:1 Cartridge)
00810000525508SmarTemp® X1 Shade B1 (50ml 10:1 Cartridge)
00810000525492SmarTemp® X1 Shade A3 (50ml 10:1 Cartridge)
00810000525485SmarTemp® X1 Shade A2 (50ml 10:1 Cartridge)
00810000525478SmarTemp® X1 Shade A1 (50ml 10:1 Cartridge)
10810000526953Mixing Tip with Blue Base for 50ml SmarTemp® (Pkg. of 30 pcs.)

Trademark Results [SmarTemp]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SMARTEMP
SMARTEMP
97794199 not registered Live/Pending
Littleone Inc.
2023-02-14
SMARTEMP
SMARTEMP
87796038 not registered Dead/Abandoned
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.
2018-02-13
SMARTEMP
SMARTEMP
85065715 4099756 Live/Registered
NOL LINER (PTE.) LTD.
2010-06-17
SMARTEMP
SMARTEMP
79184430 not registered Dead/Abandoned
KAIP Pty Limited
2016-01-21
SMARTEMP
SMARTEMP
79184244 5010373 Live/Registered
KAIP Pty Limited
2015-12-17
SMARTEMP
SMARTEMP
79078915 3922171 Live/Registered
KAIP Pty Limited
2010-01-22
SMARTEMP
SMARTEMP
78032030 2622302 Dead/Cancelled
APPLICA CONSUMER PRODUCTS, INC.
2000-10-24
SMARTEMP
SMARTEMP
78009029 not registered Dead/Abandoned
Endocare, Inc.
2000-05-19
SMARTEMP
SMARTEMP
75504038 2358459 Live/Registered
Parkell, Inc.
1998-06-17
SMARTEMP
SMARTEMP
75487052 not registered Dead/Abandoned
Peregrine Industries, Inc.
1998-05-18
SMARTEMP
SMARTEMP
75470127 2427265 Dead/Cancelled
COOKTEK INDUCTION SYSTEMS, LLC
1998-04-20
SMARTEMP
SMARTEMP
75155413 not registered Dead/Abandoned
Yarbrough, Merrill
1996-08-26

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