DEVICE: LOCATOR, compatible with Ankylos System (00840481127298)

Device Identifier (DI) Information

LOCATOR, compatible with Ankylos System
08569
In Commercial Distribution
08569-FD
Zest Anchors, LLC
00840481127298
GS1

1
078387192 *Terms of Use
LOCATOR Processing Spacer (4 Pack)
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
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?
44575 Dental impression spacer
A device comprised of thin layers of wax or other plastic materials intended to be applied to the surface of edentulous ridges and dental structures before the preliminary application of impression material. After producing the preliminary model, the device is discarded, thus providing an equidistant space between the oral structures and the impression tray that allows escape of excess impression material and entrapped air, and facilitates manipulation during final impression taking. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
NDP Accessories, implant, dental, endosseous
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

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

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

4b48abf8-88cb-44e5-83d2-d671f33ad039
July 11, 2022
1
July 01, 2022
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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

[?]
Yes
No
No
Yes
No CLOSE

Customer Contact

[?]
+1(877)649-0084
quality@zestdent.com
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