C&B METABOND® S394

GUDID 00810000529070

‘A’ Gel Universal Dentin Activator 5ml. for C&B METABOND® & AMALGAMBOND®

PARKELL, INC.

Dental etching solution
Primary Device ID00810000529070
NIH Device Record Keyc6184a85-f747-4a8e-aa26-0e40c0fdff0b
Commercial Distribution StatusIn Commercial Distribution
Brand NameC&B METABOND®
Version Model NumberS394
Catalog NumberS394
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 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store all components tightly sealed in a cool, dark, low humidity environment. Refrigeration is acceptable, do not freeze. Store catalyst syringe at room temp. Bring product to room temperature.
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store all components tightly sealed in a cool, dark, low humidity environment. Refrigeration is acceptable, do not freeze. Store catalyst syringe at room temp. Bring product to room temperature.
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store all components tightly sealed in a cool, dark, low humidity environment. Refrigeration is acceptable, do not freeze. Store catalyst syringe at room temp. Bring product to room temperature.
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store all components tightly sealed in a cool, dark, low humidity environment. Refrigeration is acceptable, do not freeze. Store catalyst syringe at room temp. Bring product to room temperature.
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store all components tightly sealed in a cool, dark, low humidity environment. Refrigeration is acceptable, do not freeze. Store catalyst syringe at room temp. Bring product to room temperature.
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store all components tightly sealed in a cool, dark, low humidity environment. Refrigeration is acceptable, do not freeze. Store catalyst syringe at room temp. Bring product to room temperature.
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store all components tightly sealed in a cool, dark, low humidity environment. Refrigeration is acceptable, do not freeze. Store catalyst syringe at room temp. Bring product to room temperature.
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store all components tightly sealed in a cool, dark, low humidity environment. Refrigeration is acceptable, do not freeze. Store catalyst syringe at room temp. Bring product to room temperature.
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store all components tightly sealed in a cool, dark, low humidity environment. Refrigeration is acceptable, do not freeze. Store catalyst syringe at room temp. Bring product to room temperature.
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store all components tightly sealed in a cool, dark, low humidity environment. Refrigeration is acceptable, do not freeze. Store catalyst syringe at room temp. Bring product to room temperature.
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store all components tightly sealed in a cool, dark, low humidity environment. Refrigeration is acceptable, do not freeze. Store catalyst syringe at room temp. Bring product to room temperature.
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store all components tightly sealed in a cool, dark, low humidity environment. Refrigeration is acceptable, do not freeze. Store catalyst syringe at room temp. Bring product to room temperature.
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store all components tightly sealed in a cool, dark, low humidity environment. Refrigeration is acceptable, do not freeze. Store catalyst syringe at room temp. Bring product to room temperature.
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store all components tightly sealed in a cool, dark, low humidity environment. Refrigeration is acceptable, do not freeze. Store catalyst syringe at room temp. Bring product to room temperature.
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store all components tightly sealed in a cool, dark, low humidity environment. Refrigeration is acceptable, do not freeze. Store catalyst syringe at room temp. Bring product to room temperature.
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store all components tightly sealed in a cool, dark, low humidity environment. Refrigeration is acceptable, do not freeze. Store catalyst syringe at room temp. Bring product to room temperature.
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store all components tightly sealed in a cool, dark, low humidity environment. Refrigeration is acceptable, do not freeze. Store catalyst syringe at room temp. Bring product to room temperature.
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100810000529070 [Primary]

FDA Product Code

EMACement, Dental

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-12-24
Device Publish Date2018-11-23

On-Brand Devices [C&B METABOND®]

00810000529230L-Powder Clear 3 grams for C&B METABOND®
00810000529223‘B’ Quick Base 10ml. for C&B METABOND®
00810000529216L-Radiopaque Tooth Shade Powder 5grams for C&B METABOND®
00810000529209Enamel Etchant Gel (Red) 5ml. for C&B METABOND®
00810000529193‘A’ Liquid Universal Dentin Activator 6ml. for C&B METABOND® & AMALGAMBOND®
00810000529162C&B METABOND® Adhesive Cement System
00810000529070‘A’ Gel Universal Dentin Activator 5ml. for C&B METABOND® & AMALGAMBOND®
M595S3950Enamel Etchant Gel (Red) 5ml. for C&B METABOND®
00810000529186Ceramic Mixing Dish for C&B MetaBond®
00810000529643Measuring Scoops for C&B MetaBond® Powder

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