AccessGUDID - DEVICE: Smartbrush 2 (08800000981512)

GUDID

Device Identifier (DI) Information

Brand Name: Smartbrush 2
Version or Model: OPISB24L
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Osstem Implant Co., Ltd.

Primary DI Number: 08800000981512
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 689051793 *Terms of Use

Device Description: No description.

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:	Yes
Prescription Use (Rx):	Yes
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?
57955	Dental implant/teeth debridement brush, non-biodegradable	A rotary/oscillating dental instrument intended to be used by a dental hygienist and/or dentist for the non-surgical-invasive debridement of a patient's dental implants and/or teeth affected by peri-implant disease (peri-implant mucositis, peri-implantitis) or periodontitis. It is a brush-like device, typically consisting of titanium bristles at the distal end of a high-grade steel shaft, that is held in a dental handpiece which provides its rotation for the mechanical removal of biofilm from the surface of the implants and teeth. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NDP	Accessories, Implant, Dental, Endosseous

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: e60bd6b8-b738-466a-ac95-6faed50bad6b
Public Version Date: December 16, 2022
Public Version Number: 1
DI Record Publish Date: December 08, 2022

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: Yes
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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