Hygiene Direct 135-1400

GUDID D77813514000

HYGIENE SELECT PETITE PRO PROPHY HP 5K SILVER

SCOTT'S DENTAL SUPPLY L.L.C.

Pneumatic dental scaling/debridement system handpiece

• Primary Device ID: D77813514000
• NIH Device Record Key: 2ef0ad62-e843-49be-8ae7-321ed3e3c059
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hygiene Direct
• Version Model Number: 135-1400
• Catalog Number: 135-1400
• Company DUNS: 137217043
• Company Name: SCOTT'S DENTAL SUPPLY L.L.C.
• 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: (800) 901-3368
• Email: info@scottsdental.com
• Phone: (800) 901-3368
• Email: info@scottsdental.com
• Phone: (800) 901-3368
• Email: info@scottsdental.com
• Phone: (800) 901-3368
• Email: info@scottsdental.com
• Phone: (800) 901-3368
• Email: info@scottsdental.com
• Phone: (800) 901-3368
• Email: info@scottsdental.com
• Phone: (800) 901-3368
• Email: info@scottsdental.com
• Phone: (800) 901-3368
• Email: info@scottsdental.com
• Phone: (800) 901-3368
• Email: info@scottsdental.com
• Phone: (800) 901-3368
• Email: info@scottsdental.com
• Phone: (800) 901-3368
• Email: info@scottsdental.com
• Phone: (800) 901-3368
• Email: info@scottsdental.com
• Phone: (800) 901-3368
• Email: info@scottsdental.com
• Phone: (800) 901-3368
• Email: info@scottsdental.com
• Phone: (800) 901-3368
• Email: info@scottsdental.com
• Phone: (800) 901-3368
• Email: info@scottsdental.com
• Phone: (800) 901-3368
• Email: info@scottsdental.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D77813514000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K073652

FDA Product Code

• EFB: Handpiece, Air-Powered, Dental

Sterilization

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

[D77813514000]

Moist Heat or Steam Sterilization

[D77813514000]

Moist Heat or Steam Sterilization

[D77813514000]

Moist Heat or Steam Sterilization

[D77813514000]

Moist Heat or Steam Sterilization

[D77813514000]

Moist Heat or Steam Sterilization

[D77813514000]

Moist Heat or Steam Sterilization

[D77813514000]

Moist Heat or Steam Sterilization

[D77813514000]

Moist Heat or Steam Sterilization

[D77813514000]

Moist Heat or Steam Sterilization

[D77813514000]

Moist Heat or Steam Sterilization

[D77813514000]

Moist Heat or Steam Sterilization

[D77813514000]

Moist Heat or Steam Sterilization

[D77813514000]

Moist Heat or Steam Sterilization

[D77813514000]

Moist Heat or Steam Sterilization

[D77813514000]

Moist Heat or Steam Sterilization

[D77813514000]

Moist Heat or Steam Sterilization

[D77813514000]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-07-16
• Device Publish Date: 2024-07-08