DEVICE: Alpha-Seal® (D73540101030020)

Device Identifier (DI) Information

Alpha-Seal®
401.0103.002
In Commercial Distribution
401.0103.002
DENTAL TECHNOLOGIES, INC.
D73540101030020
HIBCC

1
148312838 *Terms of Use
Alpha-Seal® is a light cure resin-based Pit & Fissure Sealant with fluoride. This sealant contains 50% radiopaque nano-sized fillers. The hard setting, wear resistant material has an ideal flowable viscosity for maximum coverage and protection to seal the pits and fissures of teeth suseptible to caries. The syringe needle tips allow for quick and accurate placement of the material. Alpha-Seal® is available in Opaque shade to allow for easy identification during patient examinations and in a Clear shade for patients who wish to have an "invisible" sealant. Kit Contains: 1 x 1.5g Sealant Syringe (Opaque White), 3 Dispensing Tips
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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

51ec993f-7db7-4639-89a5-37d90cf33566
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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