DEVICE: ALPHA-DENT® Light Cure Pit & Fissure Sealant (D73540100000010)

Device Identifier (DI) Information

ALPHA-DENT® Light Cure Pit & Fissure Sealant
401.0000.001
In Commercial Distribution
401.0000.001
DENTAL TECHNOLOGIES, INC.
D73540100000010
HIBCC

1
148312838 *Terms of Use
ALPHA-DENT® Light Cure Pit & Fissure Sealant is a hard-setting, wear resistent, un-filled resin based material that has ideal flowable viscosity for maximum coverage and protection to seal pits and fissures of teeth susceptible to caries. Kit Contains: 2 x 3ml Sealant (Opaque White), 7ml Etch Liquid, Dispensing Pad
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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
Dental pit/fissure sealant A resin-based dental material suitable for sealing pits and fissures on teeth. It may be chemically cured or external energy cured. 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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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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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 2 and 27 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

38eeb9d0-cf91-4679-89e3-9a3fce06fb4c
March 29, 2018
2
September 23, 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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847-677-5500
info@dentaltech.com
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