55000

GUDID D746550000

Anter Needle Diamond ARS Bur 5PK

DENTSPLY SIRONA ORTHODONTICS INC.

Diamond dental bur, reusable

• Primary Device ID: D746550000
• NIH Device Record Key: b11774ab-56c8-4d1b-85d2-dd50bc81e6a7
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 55000
• Catalog Number: 55000
• Company DUNS: 116903307
• Company Name: DENTSPLY SIRONA ORTHODONTICS INC.
• Device Count: 5
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• Serial Number: false
• Manufacturing Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D746550000 [Unit of Use]
HIBCC	D746550001 [Primary]

FDA Product Code

• EJL: Bur, Dental

Sterilization

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

[D746550000]

Moist Heat or Steam Sterilization

[D746550000]

Moist Heat or Steam Sterilization

[D746550000]

Moist Heat or Steam Sterilization

[D746550000]

Moist Heat or Steam Sterilization

[D746550000]

Moist Heat or Steam Sterilization

[D746550000]

Moist Heat or Steam Sterilization

[D746550000]

Moist Heat or Steam Sterilization

[D746550000]

Moist Heat or Steam Sterilization

[D746550000]

Moist Heat or Steam Sterilization

[D746550000]

Moist Heat or Steam Sterilization

[D746550000]

Moist Heat or Steam Sterilization

[D746550000]

Moist Heat or Steam Sterilization

[D746550000]

Moist Heat or Steam Sterilization

[D746550000]

Moist Heat or Steam Sterilization

[D746550000]

Moist Heat or Steam Sterilization

[D746550000]

Moist Heat or Steam Sterilization

[D746550000]

Moist Heat or Steam Sterilization

[D746550000]

Moist Heat or Steam Sterilization

[D746550000]

Moist Heat or Steam Sterilization

[D746550000]

Moist Heat or Steam Sterilization

[D746550000]

Moist Heat or Steam Sterilization

[D746550000]

Moist Heat or Steam Sterilization

[D746550000]

Moist Heat or Steam Sterilization

[D746550000]

Moist Heat or Steam Sterilization

[D746550000]

Moist Heat or Steam Sterilization

[D746550000]

Moist Heat or Steam Sterilization

[D746550000]

Moist Heat or Steam Sterilization

[D746550000]

Moist Heat or Steam Sterilization

[D746550000]

Moist Heat or Steam Sterilization

[D746550000]

Moist Heat or Steam Sterilization

[D746550000]

Moist Heat or Steam Sterilization

[D746550000]

Moist Heat or Steam Sterilization

[D746550000]

Moist Heat or Steam Sterilization

[D746550000]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-12-31
• Device Publish Date: 2021-12-23

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• D74666595561 - Sculpt I.Q.: 2024-02-02 Wireless Foot Control
• D74666591841 - Sculpt I.Q.: 2024-01-26 Handpiece sleeve with keypad