AccessGUDID - DEVICE: SM3 (08800000995229)

GUDID

Device Identifier (DI) Information

Brand Name: SM3
Version or Model: S200EL
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Osstem Implant Co., Ltd._Gasan Branch

Primary DI Number: 08800000995229
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 689515024 *Terms of Use

Device Description: S200EL Contra angle only - The SM3 is intended for use in dental oral surgery and dental implant. The main unit is designed to be used with a specific dental micromotor that drives dental handpieces fitted with appropriate tools to cut hard tissues in the mouth.

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?
38347	Dental power tool system handpiece, line-powered	A hand-held, mains electricity (AC-powered) dental device that includes a chuck or collet for attaching a dental endpiece (e.g., drill bit, bur, reamer, saw blade, polishing disk) intended to be used in dentistry to bore/excavate bones, teeth, and tough tissues. It is powered by a low-voltage electric micro-motor (e.g., 24 volt) that is an integral part of the device; the endpiece(s) are not included. It is typically connected through the dental delivery system or a freestanding independent control unit. This is a reusable device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
KMW	Handpiece, Rotary Bone Cutting
EGS	Handpiece, Contra- And Right-Angle Attachment, Dental
EBW	Controller, Foot, Handpiece And Cord

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No 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: 560ae171-c5ad-480b-ab3f-d24ef333987d
Public Version Date: May 03, 2019
Public Version Number: 1
DI Record Publish Date: April 25, 2019