SABLE Rotamax PRO 45KL

GUDID 00841359010056

SABLE Rotamax PRO 45KL is a 45 degree Push Button Fiber Optic High Speed Handpiece

Sable Industries Inc

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• Primary Device ID: 00841359010056
• NIH Device Record Key: f14afede-fae9-497e-8432-b34e6e547721
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SABLE Rotamax PRO 45KL
• Version Model Number: 2000023
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841359010056 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K072554

FDA Product Code

• EFB: Handpiece, Air-Powered, Dental

Sterilization

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

[00841359010056]

Moist Heat or Steam Sterilization

[00841359010056]

Moist Heat or Steam Sterilization

[00841359010056]

Moist Heat or Steam Sterilization

[00841359010056]

Moist Heat or Steam Sterilization

[00841359010056]

Moist Heat or Steam Sterilization

[00841359010056]

Moist Heat or Steam Sterilization

[00841359010056]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-07-13
• Device Publish Date: 2022-07-05

Devices Manufactured by Sable Industries Inc

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• 00841359040046 - SABLE U-Type: 2023-02-16 SABLE U-Type BB Push Latch Head,20,000 RPM - Sectional
• 00841359030054 - SABLE 20K Air Motor: 2022-12-09 NSK Type 20K mini Air Motor
• 00841359060105 - SABLE - Doctor's Package: 2022-10-06 Doctor's One Piece 1:1 Push Button Latch E-Type Package Package contains: Air Motor (1600110), Contra Angle (1600214)
• 00841359060112 - SABLE - Doctor's Package: 2022-10-06 Doctor's One-Piece 1:1 Push Button F.G. E-Type Package Package Contains: Air Motor (1600110), Contra Angle (1600215)
• 00841359060129 - SABLE - Hygienist Package: 2022-10-06 Hygienist One Piece 4:1 Screw-In E-Type Package Package Contains: Air Motor (1600110), Contra Angle (1600216)
• 00841359060136 - SABLE - Hygienist Package: 2022-10-06 Hygienist One Piece 4:1 Push Button Latch E-Type Package Package Contains: Air Motor (1600110), Contra Angle (1600218)
• 00841359060013 - SABLE - Doctor's Package: 2022-08-08 SABLE - NSK Type Doctor's Swing Latch Head Package. Package contains - Air Motor (1600110), 1:1 Contra Angle (1600210), 1:1 No