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

• 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