DEVICE: Bone Level UCLA (D78532530UCLANEDEL0)

Device Identifier (DI) Information

Bone Level UCLA
3.25mm UCLA NE (DEL)
In Commercial Distribution
32530 UCLA NE (DEL)
OCO BIOMEDICAL INC
D78532530UCLANEDEL0
HIBCC

1
094146123 *Terms of Use
3.25mm UCLA NE (DEL) 3.25mm Diameter Non-Engaging Delrin Base
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Device Characteristics

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

GMDN

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

GMDN Preferred Term Name GMDN Definition
Dental implant system A collection of devices designed for the surgical placement of a dental implant into alveolar and/ or basal bone of the mandible or maxilla to provide support and a means of retention for a dental prosthesis (e.g., bridge, single-tooth, overdenture). It typically consists of a sterile endosteal dental implant (implant body and abutment) and surgical instruments for implantation.
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FDA Product Code

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Product Code Product Code Name
NHA Abutment, Implant, Dental, Endosseous
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FDA Premarket Submission

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

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Size Type Text
No Device Sizes
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Device Record Status

ce8192d9-2b6a-4dac-91e9-7f0aa2d70e7b
March 29, 2018
2
April 13, 2016
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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

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
Yes
No
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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