SABLE U-Type

GUDID 00841359040022

SABLE U-Type Standard Latch Head 5,000 RPM - Non Sectional

Sable Industries Inc

Dental power tool handpiece motorless component Dental power tool handpiece motorless component Dental power tool handpiece motorless component Dental power tool handpiece motorless component Dental power tool handpiece motorless component Dental power tool handpiece motorless component Dental power tool handpiece motorless component Dental power tool handpiece motorless component Dental power tool handpiece motorless component Dental power tool handpiece motorless component Dental power tool handpiece motorless component

• Primary Device ID: 00841359040022
• NIH Device Record Key: 1c08b7aa-4f00-4c40-9f1c-2f414cff763d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SABLE U-Type
• Version Model Number: 1300301
• Company DUNS: 255407272
• Company Name: Sable Industries 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-800-368-8106
• Email: info@sableindustriesinc.com
• Phone: 1-800-368-8106
• Email: info@sableindustriesinc.com
• Phone: 1-800-368-8106
• Email: info@sableindustriesinc.com
• Phone: 1-800-368-8106
• Email: info@sableindustriesinc.com
• Phone: 1-800-368-8106
• Email: info@sableindustriesinc.com
• Phone: 1-800-368-8106
• Email: info@sableindustriesinc.com
• Phone: 1-800-368-8106
• Email: info@sableindustriesinc.com
• Phone: 1-800-368-8106
• Email: info@sableindustriesinc.com
• Phone: 1-800-368-8106
• Email: info@sableindustriesinc.com
• Phone: 1-800-368-8106
• Email: info@sableindustriesinc.com
• Phone: 1-800-368-8106
• Email: info@sableindustriesinc.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841359040022 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083101

FDA Product Code

• EFB: Handpiece, Air-Powered, Dental

Sterilization

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

[00841359040022]

Moist Heat or Steam Sterilization

[00841359040022]

Moist Heat or Steam Sterilization

[00841359040022]

Moist Heat or Steam Sterilization

[00841359040022]

Moist Heat or Steam Sterilization

[00841359040022]

Moist Heat or Steam Sterilization

[00841359040022]

Moist Heat or Steam Sterilization

[00841359040022]

Moist Heat or Steam Sterilization

[00841359040022]

Moist Heat or Steam Sterilization

[00841359040022]

Moist Heat or Steam Sterilization

[00841359040022]

Moist Heat or Steam Sterilization

[00841359040022]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-08-05
• Device Publish Date: 2022-07-28

On-Brand Devices [SABLE U-Type]

• 00841359040169: SABLE U-Type Screw-In Prophy Head - 5,000 RPM
• 00841359040152: SABLE U-Type Snap-On Prophy Head
• 00841359040039: SABLE U-Type Standard Latch Head 5,000 RPM - Sectional
• 00841359040022: SABLE U-Type Standard Latch Head 5,000 RPM - Non Sectional
• 00841359040015: SABLE U-Type Friction Grip Head
• 00841359040046: SABLE U-Type BB Push Latch Head,20,000 RPM - Sectional