DEVICE: Procera Esthetic Abutment (07332747002249)

Device Identifier (DI) Information

Procera Esthetic Abutment
33763
In Commercial Distribution
33763
Nobel Biocare AB
07332747002249
GS1

1
353939929 *Terms of Use
Procera Esthetic Abutment BmkSyst RP #10
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Dental implant suprastructure, permanent, preformed A prefabricated device intended to provide a permanent intermediate fixture level between a dental implant and the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It includes one or more structural component(s) [e.g., abutment, ball, bar, bar overlay, coping], and may be made of various materials [e.g., titanium (Ti), plastic, gold alloy]; an abutment screw(s) may be included, however the suprastructure does not represent the screw(s) in isolation. It may also be referred to as an abutment assembly or mesostructure.
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FDA Product Code

[?]
Product Code Product Code Name
NHA ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K031719 000
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Sterilization

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

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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

5f86287e-848c-4af1-bb85-46c57b0a14cf
July 06, 2018
4
September 17, 2015
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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

[?]
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
No
No CLOSE

Customer Contact

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