SM3

GUDID 08800000995274

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.

Osstem Implant Co., Ltd._Gasan Branch

Dental power tool system handpiece, line-powered

• Primary Device ID: 08800000995274
• NIH Device Record Key: 560ae171-c5ad-480b-ab3f-d24ef333987d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SM3
• Version Model Number: S200EL
• Company DUNS: 689515024
• Company Name: Osstem Implant Co., Ltd._Gasan Branch
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800000995229 [Primary]
GS1	08800000995274 [Direct Marking]

FDA Product Code

• KMW: Handpiece, Rotary Bone Cutting

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[08800000995274]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-05-03
• Device Publish Date: 2019-04-25

On-Brand Devices [SM3]

• 08800000995236: Motor and cord set - The SM3 is intended for use in dental oral surgery and dental implant. The
• 08800000995274: S200EL Contra angle only - The SM3 is intended for use in dental oral surgery and dental implant
• 08800000995212: SM3 complete set - The SM3 is intended for use in dental oral surgery and dental implant. The ma