DEVICE: PRIME&BOND XP (D010606674011)

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Device Record History
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Device Identifier (DI) Information
PRIME&BOND XP
60667401
In Commercial Distribution
60667401
Dentsply De Trey GmbH
D010606674011
HIBCC

1
315471722 *Terms of Use
PRIME&BOND XP ECO Refill is a universal Total-Etch Dental Adhesive. Prime&Bond XP Refill is received in a bottle delivery (D010K3027610). With its supporting accessories (Applicator Tips and Clixdish) it can be classified as a convenience kit.
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
Yes
No
Yes
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
42483 Dentine adhesive
A material primarily used as a bonding-promoting substance between dentine and a composite filling, restorative or luting material. It may also be used as a bonding substance to enamel. After application, this device cannot be reused.
Obsolete false
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FDA Product Code

[?]
Product Code Product Code Name
KLE AGENT, TOOTH BONDING, RESIN
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization
No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 10 and 28 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: Liquid
Total Volume: 5 Milliliter
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Device Record Status
603d6b87-f927-4982-bdb6-a54356a5296b
March 29, 2018
2
September 20, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
Yes
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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