Prime&Bond active 60667341

GUDID D010606673411

Prime&Bond active Standard Refill universal adhesive is a combined Etch&Rinse (Total Etch), Self Etch and Selective Etch adhesive. It offers a simple adhesive application technique for both direct and indirect indications and bonds to enamel, dentin, composites, zirconia and metals.

Dentsply De Trey GmbH

Dentine bonding agent/set
Primary Device IDD010606673411
NIH Device Record Key198005ff-4734-4ebb-b572-a3fb0f012f7c
Commercial Distribution StatusIn Commercial Distribution
Brand NamePrime&Bond active
Version Model Number60667341
Catalog Number60667341
Company DUNS315471722
Company NameDentsply De Trey GmbH
Device Count1
DM Exempttrue
Pre-market Exempttrue
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

Device Dimensions

Device Size Text, specify0
Total Volume4 Milliliter
Device Size Text, specify0
Total Volume4 Milliliter
Device Size Text, specify0
Total Volume4 Milliliter
Device Size Text, specify0
Total Volume4 Milliliter
Device Size Text, specify0
Total Volume4 Milliliter
Device Size Text, specify0
Total Volume4 Milliliter
Device Size Text, specify0
Total Volume4 Milliliter
Device Size Text, specify0
Total Volume4 Milliliter
Device Size Text, specify0
Total Volume4 Milliliter
Device Size Text, specify0
Total Volume4 Milliliter
Device Size Text, specify0
Total Volume4 Milliliter
Device Size Text, specify0
Total Volume4 Milliliter
Device Size Text, specify0
Total Volume4 Milliliter

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 24 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep the product out of direct sunlight and store in a well-ventilated place.
Storage Environment TemperatureBetween 2 Degrees Celsius and 24 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep the product out of direct sunlight and store in a well-ventilated place.
Storage Environment TemperatureBetween 2 Degrees Celsius and 24 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep the product out of direct sunlight and store in a well-ventilated place.
Storage Environment TemperatureBetween 2 Degrees Celsius and 24 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep the product out of direct sunlight and store in a well-ventilated place.
Storage Environment TemperatureBetween 2 Degrees Celsius and 24 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep the product out of direct sunlight and store in a well-ventilated place.
Storage Environment TemperatureBetween 2 Degrees Celsius and 24 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep the product out of direct sunlight and store in a well-ventilated place.
Storage Environment TemperatureBetween 2 Degrees Celsius and 24 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep the product out of direct sunlight and store in a well-ventilated place.
Storage Environment TemperatureBetween 2 Degrees Celsius and 24 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep the product out of direct sunlight and store in a well-ventilated place.
Storage Environment TemperatureBetween 2 Degrees Celsius and 24 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep the product out of direct sunlight and store in a well-ventilated place.
Storage Environment TemperatureBetween 2 Degrees Celsius and 24 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep the product out of direct sunlight and store in a well-ventilated place.
Storage Environment TemperatureBetween 2 Degrees Celsius and 24 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep the product out of direct sunlight and store in a well-ventilated place.
Storage Environment TemperatureBetween 2 Degrees Celsius and 24 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep the product out of direct sunlight and store in a well-ventilated place.
Storage Environment TemperatureBetween 2 Degrees Celsius and 24 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep the product out of direct sunlight and store in a well-ventilated place.

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD010606673411 [Primary]

FDA Product Code

KLEAGENT, TOOTH BONDING, RESIN

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2024-02-16
Device Publish Date2018-11-15

On-Brand Devices [Prime&Bond active]

D010606673541Prime&Bond active® universal adhesive is a combined Etch&Rinse (Total-Etch), Self-Etch and Sele
D010606673531Prime&Bond active® universal adhesive is a combined Etch&Rinse (Total-Etch), Self-Etch and Sele
D010606673481Prime&Bond active® universal adhesive is a combined Etch&Rinse (Total-Etch), Self-Etch and Sele
D010606673471Prime&Bond active® universal adhesive is a combined Etch&Rinse (Total-Etch), Self-Etch and Sele
D010606673451Prime&Bond active® universal adhesive is a combined Etch&Rinse (Total-Etch), Self-Etch and Sele
D010606673441Prime&Bond active® universal adhesive is a combined Etch&Rinse (Total-Etch), Self-Etch and Sele
D010606673431Prime&Bond active® universal adhesive is a combined Etch&Rinse (Total-Etch), Self-Etch and Sele
D010606673421Prime&Bond active® universal adhesive is a combined Etch&Rinse (Total-Etch), Self-Etch and Sele
D010606673401Prime&Bond active® universal adhesive is a combined Etch&Rinse (Total-Etch), Self-Etch and Sele
D010606673411Prime&Bond active Standard Refill universal adhesive is a combined Etch&Rinse (Total Etch), Self
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