DEVICE: Admira Protect (E22116501)

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Device Identifier (DI) Information

Admira Protect
1650
1650
VOCO GmbH
E22116501
HIBCC
1
Light-curing self-etch-bond reinforced with nano-fillers. Chemical-curing in areas inaccessible with a curing light. Futurabond DC achieves the same adhesive properties as total-etch preparations without seperate etching of the tooth substance. Moisture-tolerant. Durable marginal integrity. Easy and fast application - one-coat, one-cure technique. contains fluorides. No refrigerated storage needed. Ideal for paediatric use.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
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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
Dental unfilled resin sealant/coating A non-sterile, resin-based dental material intended for professional use as a sealant, coating, and/or glazing material during dental restoration (e.g., pit/fissure sealing and/or restorative composite resin sealing/coating), whereby the majority of the setting reaction is based on the self-, light-, or dual-cured polymerization of an unfilled resin; it does not include any significant inorganic filler materials and is therefore not classed as a composite resin. It may be preloaded into an applicator. After application, this device cannot be reused.
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FDA Product Code

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Product Code Product Code Name
EBC Sealant, Pit And Fissure, And Conditioner
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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 Status

In Commercial Distribution
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: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
No
No CLOSE

Customer Contact

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999-999-9999
xxx@xx.xx
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