DEVICE: SYNOCTA PROSTHETICS (07630031725615)

Device Identifier (DI) Information

SYNOCTA PROSTHETICS
1
In Commercial Distribution
048.662
Institut Straumann AG
07630031725615
GS1

1
483599259 *Terms of Use
RN synOcta® Plastic Coping for 048.605, for bridge, H 7mm, POM
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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?
16189 Dental casting wax
A waxy dental material used to make patterns in the production of fixed dental prosthetic restorations by the "lost-wax" casting technique. After application, this device cannot be reused.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
DZE IMPLANT, ENDOSSEOUS, ROOT-FORM
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K990342 000
No CLOSE

Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Keep away from sunlight
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: H 7mm
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Device Record Status

e57e355b-4abb-48e3-9a7f-bc12449a6488
July 06, 2018
3
September 24, 2015
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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)

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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(800)448-8168
info.usa@straumann.com
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