AccessGUDID - DEVICE: Bioclear Instrument (D9495000211)

GUDID

Device Identifier (DI) Information

Brand Name: Bioclear Instrument
Version or Model: Sculpting Point
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Bioclear Matrix Systems

Primary DI Number: D9495000211
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 059020838 *Terms of Use

Device Description: Metal instrument used in dental restorations.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
65077	Dental restoration carver, multiple-material	A hand-held manual dental instrument intended to be used for producing and perfecting anatomical forms in multiple dental restoration materials such as amalgam, cement, and acrylic or composite resin/plastic (i.e., not dedicated to a particular material) by cutting, scraping, paring, and smoothing finishes and modelling patterns intraorally. It is typically a double-ended instrument with working ends of various shapes and designs, and a central handle. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DZN	Instruments, Dental Hand

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a0e76881-86f1-4c38-9e17-5e113a6fca70
Public Version Date: August 18, 2023
Public Version Number: 1
DI Record Publish Date: August 10, 2023

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

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

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

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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