DEVICE: Alpha-Cal® (D73541400000020)
Device Identifier (DI) Information
Alpha-Cal®
414.0000.002
In Commercial Distribution
414.0000.002
DENTAL TECHNOLOGIES, INC.
414.0000.002
In Commercial Distribution
414.0000.002
DENTAL TECHNOLOGIES, INC.
Alpha-Cal® is a calcium hydroxide paste with Barium Sulfate used as a root canal sealer for the temporary filling of root canals after conventional endodontic treatments. Alpha-Cal® is an aqueous, radiopaque, high pH (>12.0) paste packaged in a syringe ready to be dispensed through disposable tips into the root canal. Kit Contains: 4 x 1g Syringe, 8 Syringe Tips
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
No | |
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? |
---|---|---|---|---|
36095 | Endodontic filling/sealing material |
A prefabricated, solid dental substance used in endodontics to fill or permanently obturate the root canal of a tooth. The substance may set without assistance of moisture, and is typically intended for orthograde use (i.e., a root filling placed from the coronal aspect). The device has various metallic or polymeric compositions that include (but are not limited to) silver (Ag), methylmethacrylate, zinc oxide eugenol, glass alkenoate, and calcium hydroxide (Ca(OH)2). It does not include gutta-percha. After application, this device cannot be reused.
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Obsolete | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KIF | Resin, Root Canal Filling |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K963922 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between 2 and 27 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
4977b80a-0a7f-4f03-9cc6-1d412e4e0cdb
July 06, 2018
3
September 23, 2016
July 06, 2018
3
September 23, 2016
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 |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
D73541402020020
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
847-677-5500
info@dentaltech.com
info@dentaltech.com