Dentacenter Operative Dental Unit

GUDID D104SAF531SERIES2

Fully-contained mobile dental unit and accessories. The AC-powered device Is intended to supply power and to serve as a base for other dental devices such as a dental handpiece, and other dental devices and accessories.

Safari Dentaire Inc

Dental delivery system instrument unit, electric

• Primary Device ID: D104SAF531SERIES2
• NIH Device Record Key: addc73e1-1804-4922-9893-e235a73bef21
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dentacenter Operative Dental Unit
• Version Model Number: SAF-531-Series II
• Company DUNS: 245011531
• Company Name: Safari Dentaire Inc
• 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
HIBCC	D104SAF531SERIES2 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100212

FDA Product Code

• EIA: Unit, Operative Dental

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-10-10
• Device Publish Date: 2023-10-02

On-Brand Devices [Dentacenter Operative Dental Unit]

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• D104SAF60626: Fully-contained mobile dental unit and accessories. The AC-powered device Is intended to supply
• D104SAF531SERIES2: Fully-contained mobile dental unit and accessories. The AC-powered device Is intended to supply
• D104SAF500M4: Fully-contained mobile dental unit and accessories. The AC-powered device Is intended to supply
• D104SAF500M2: Fully-contained mobile dental unit and accessories. The AC-powered device Is intended to supply
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• D104SAF433XP0: Fully-contained mobile dental unit and accessories. The AC-powered device Is intended to supply
• D104SAF4303: Fully-contained mobile dental unit and accessories. The AC-powered device Is intended to supply
• D104SAF4302XP0: Fully-contained mobile dental unit and accessories. The AC-powered device Is intended to supply
• D104SAF430: Fully-contained mobile dental unit and accessories. The AC-powered device Is intended to supply
• D104SAF4302: Fully-contained mobile dental unit and accessories. The AC-powered device Is intended to supply