DEVICE: Nobel Biocare® (07332747213577)

Device Identifier (DI) Information

Nobel Biocare®
300458
In Commercial Distribution
300458
Nobel Biocare AB
07332747213577
GS1

1
353939929 *Terms of Use
Position Locator Single Abut Nobel Biocare CC RP
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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?
61640 Dental implant abutment analog, laboratory
A rod-like device intended to be used as a copy of a dental implant abutment, for a dental laboratory working model, to confirm the orientation/position of the final dental implant; it may be used during a scanning procedure (e.g., with a laboratory scanner). This is a reusable 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
Special Storage Condition, Specify: Keep away from sunlight. Keep dry
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Clinically Relevant Size

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

fb45e9da-f5dd-454b-9684-97404448b68a
May 26, 2025
1
May 16, 2025
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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
No
Yes
No CLOSE

Customer Contact

[?]
+1(800)322-5001
us.customerservice@nobelbiocare.com
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