Absolute Dentin™ S301

GUDID 00810000525034

Absolute Dentin™ 50ml - Tooth Shade

PARKELL, INC.

Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin
Primary Device ID00810000525034
NIH Device Record Key465387a2-05de-46b8-a1a4-7133ccacda14
Commercial Distribution StatusIn Commercial Distribution
Brand NameAbsolute Dentin™
Version Model NumberS301
Catalog NumberS301
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
Phone6312491134
Emailcustomerservice@parkell.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 3 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 3 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 3 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 3 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the material in a cool, dry place. For longest shelf life, refrigerate without freezing. Allow to warm to room temperature.
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the material in a cool, dry place. For longest shelf life, refrigerate without freezing. Allow to warm to room temperature.
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the material in a cool, dry place. For longest shelf life, refrigerate without freezing. Allow to warm to room temperature.
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the material in a cool, dry place. For longest shelf life, refrigerate without freezing. Allow to warm to room temperature.
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the material in a cool, dry place. For longest shelf life, refrigerate without freezing. Allow to warm to room temperature.
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the material in a cool, dry place. For longest shelf life, refrigerate without freezing. Allow to warm to room temperature.
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the material in a cool, dry place. For longest shelf life, refrigerate without freezing. Allow to warm to room temperature.
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the material in a cool, dry place. For longest shelf life, refrigerate without freezing. Allow to warm to room temperature.
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the material in a cool, dry place. For longest shelf life, refrigerate without freezing. Allow to warm to room temperature.
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the material in a cool, dry place. For longest shelf life, refrigerate without freezing. Allow to warm to room temperature.
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the material in a cool, dry place. For longest shelf life, refrigerate without freezing. Allow to warm to room temperature.
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the material in a cool, dry place. For longest shelf life, refrigerate without freezing. Allow to warm to room temperature.
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the material in a cool, dry place. For longest shelf life, refrigerate without freezing. Allow to warm to room temperature.
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the material in a cool, dry place. For longest shelf life, refrigerate without freezing. Allow to warm to room temperature.
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the material in a cool, dry place. For longest shelf life, refrigerate without freezing. Allow to warm to room temperature.
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the material in a cool, dry place. For longest shelf life, refrigerate without freezing. Allow to warm to room temperature.
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the material in a cool, dry place. For longest shelf life, refrigerate without freezing. Allow to warm to room temperature.
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100810000525034 [Primary]

FDA Product Code

EBFMaterial, Tooth Shade, 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 [Absolute Dentin™]

00810000525065Absolute Dentin™ 50ml - Blue
00810000525034Absolute Dentin™ 50ml - Tooth Shade
00810000525027Absolute Dentin™ 50ml - Arctic White
00810000525010Absolute Dentin™ - LV 5ml Syringe (TOOTH SHADE)
00810000525003Absolute Dentin™ - LV 5ml Syringe (WHITE SHADE)
M595S3070Absolute Dentin™ 50ml - Blue
M595S305110ml. Tooth Shade Absolute Dentin™ (2 Cartridges; 20ml. Total)
M595S304110ml. Artic White Absolute Dentin™ (2 Cartridges; 20ml. Total)
M595S3010Absolute Dentin™ 50ml - Tooth Shade
M595S3000Absolute Dentin™ 50ml - White
1081000052505510ml. Tooth Shade Absolute Dentin™ (2 Cartridges; 20ml. Total)
1081000052504810ml. Artic White Absolute Dentin™ (2 Cartridges; 20ml. Total)
00810000525560Absolute Dentin™ 50ml - Blue for Korea
00810000525553Absolute Dentin™ 50ml - Tooth Shade for Korea
00810000525546Absolute Dentin™ 50ml - Arctic White for Korea
0081000052561410ml. Tooth Shade Absolute Dentin™ (2 Cartridges; 20ml. Total)(Korea)
0081000052560710ml. Artic White Absolute Dentin™ (2 Cartridges; 20ml. Total) (Korea)
10810000526939White Root Canal Tip for Use on S334 Mixing Tip (Pkg. of 50 pcs.)
10810000526922Mixing Tip with Brown Base for 5ml Absolute Dentin™ Plus (Pkg. of 30 pcs.)
10810000526885Dark Grey Intraoral Tip for Use on S302 Tip (Pkg. of 50 pcs.)
10810000526878Yellow Intraoral Tip for Use on S302 Mixing Tip (Pkg. of 50 pcs.)
10810000526861Mixing Tip with Yellow Base for 50ml Absolute Dentin™, Mach-2®, Mach-SLO™ & SHARP™ Wash (

Trademark Results [Absolute Dentin]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ABSOLUTE DENTIN
ABSOLUTE DENTIN
87216624 5217575 Live/Registered
Parkell, Inc.
2016-10-26

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.