DEVICE: Futurabond NR (E22111521)

Device Identifier (DI) Information

Futurabond NR
1152
In Commercial Distribution
1152
VOCO GmbH
E22111521
HIBCC

50
316699578 *Terms of Use
Light-curing self-etch-bond reinforced with nano-fillers. Excellent adhesion to dentine and enamel. Durable marginal integrity. Moisture-tolerant. Easy and fast application - on-coat, one-cure technique. Universal for all light-curing restoratives. Ideal for paediatric use. Contains fluorides. No refrigerated storage needed.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Dentine bonding agent/set A material(s) primarily intended to be used as a bonding-promoting substance between dentine and a dental composite filling, restorative, or luting material. It includes a resin-based bonding agent and may also include a primer and/or etching solution (as a single formulation or as part of a set); composite resin is not included. It may also be used as an enamel bonding material. After application, this device cannot be reused.
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FDA Product Code

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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
No CLOSE

Sterilization

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

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Storage and Handling
Storage Environment Temperature: between 4 and 23 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

7502b45e-45b1-40d9-a0c8-1978ef8ddb4b
March 29, 2018
2
August 31, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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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

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Unit of Use DI Number: E22111520 CLOSE

Direct Marking (DM)

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

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Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
999-999-9999
xxx@xx.xx
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