DEVICE: Park Dental Research Corp. (D769P90510)

Device Identifier (DI) Information

Park Dental Research Corp.
P9051
In Commercial Distribution

PARK DENTAL RESEARCH CORP
D769P90510
HIBCC

1
011441508 *Terms of Use
5.0mm Depth Gauge
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
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
Implant-depth dental gauge A hand-held dental instrument used in surgical implant procedures to accurately measure various depths. This device has graduations on the measuring tip denoting specific depths (typically in millimetres) which are used at the fixture level (where a device is surgically implanted into the mandible or maxilla) to determine the correct drill depth of the implant site, or at the abutment level (where a device is screwed into the implanted fixture) for measuring the soft tissues and the mucosal height over the fixture. The device is typically available in a set of graduated sizes. This is a reusable device intended to be sterilized prior to use.
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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
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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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

709dea72-4e7b-4a99-bff7-e4e8f26fc40f
March 29, 2018
2
November 09, 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)

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

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
1-800-243-7372
info@pdrus.com
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