CAVITY ACCESS Z SET A305Z00000000

GUDID J003A305Z000000001

Endodontic Instrument

MAILLEFER INSTRUMENTS HOLDING Sàrl

Carbide dental bur, reusable Carbide dental bur, reusable Carbide dental bur, reusable Carbide dental bur, reusable Carbide dental bur, reusable Carbide dental bur, reusable Carbide dental bur, reusable Carbide dental bur, reusable Carbide dental bur, reusable Carbide dental bur, reusable Carbide dental bur, reusable Carbide dental bur, reusable Carbide dental bur, reusable Carbide dental bur, reusable Carbide dental bur, reusable Carbide dental bur, reusable Carbide dental bur, reusable Carbide dental bur, reusable Carbide dental bur, reusable Carbide dental bur, reusable Carbide dental bur, reusable Carbide dental bur, reusable Carbide dental bur, reusable Carbide dental bur, reusable Carbide dental bur, reusable Carbide dental bur, reusable Carbide dental bur, reusable Carbide dental bur, reusable Carbide dental bur, reusable

• Primary Device ID: J003A305Z000000001
• NIH Device Record Key: 9bc7fd71-a179-439d-bac3-4d767ddfc763
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CAVITY ACCESS Z SET
• Version Model Number: A305Z00000000
• Catalog Number: A305Z00000000
• Company DUNS: 480538495
• Company Name: MAILLEFER INSTRUMENTS HOLDING Sàrl
• Device Count: 1
• 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *N/A
• Special Storage Condition, Specify: Between 0 and 0 *N/A
• Special Storage Condition, Specify: Between 0 and 0 *N/A
• Special Storage Condition, Specify: Between 0 and 0 *N/A
• Special Storage Condition, Specify: Between 0 and 0 *N/A
• Special Storage Condition, Specify: Between 0 and 0 *N/A
• Special Storage Condition, Specify: Between 0 and 0 *N/A
• Special Storage Condition, Specify: Between 0 and 0 *N/A
• Special Storage Condition, Specify: Between 0 and 0 *N/A
• Special Storage Condition, Specify: Between 0 and 0 *N/A
• Special Storage Condition, Specify: Between 0 and 0 *N/A
• Special Storage Condition, Specify: Between 0 and 0 *N/A
• Special Storage Condition, Specify: Between 0 and 0 *N/A
• Special Storage Condition, Specify: Between 0 and 0 *N/A
• Special Storage Condition, Specify: Between 0 and 0 *N/A
• Special Storage Condition, Specify: Between 0 and 0 *N/A
• Special Storage Condition, Specify: Between 0 and 0 *N/A
• Special Storage Condition, Specify: Between 0 and 0 *N/A
• Special Storage Condition, Specify: Between 0 and 0 *N/A
• Special Storage Condition, Specify: Between 0 and 0 *N/A
• Special Storage Condition, Specify: Between 0 and 0 *N/A
• Special Storage Condition, Specify: Between 0 and 0 *N/A
• Special Storage Condition, Specify: Between 0 and 0 *N/A
• Special Storage Condition, Specify: Between 0 and 0 *N/A
• Special Storage Condition, Specify: Between 0 and 0 *N/A
• Special Storage Condition, Specify: Between 0 and 0 *N/A
• Special Storage Condition, Specify: Between 0 and 0 *N/A
• Special Storage Condition, Specify: Between 0 and 0 *N/A
• Special Storage Condition, Specify: Between 0 and 0 *N/A

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	J003A305Z000000001 [Primary]

FDA Product Code

• EJL: BUR, DENTAL

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-11-28
• Device Publish Date: 2022-11-20

Devices Manufactured by MAILLEFER INSTRUMENTS HOLDING Sàrl

• J003A0165321001001 - DIAMENDO: 2022-11-28 Dental burs
• J003A0165325002001 - DIAMENDO: 2022-11-28 Dental burs
• J003A0305000000001 - CAVITY ACCESS SET: 2022-11-28 Endodontic Instrument
• J003A305Z000000001 - CAVITY ACCESS Z SET: 2022-11-28Endodontic Instrument
• J003A305Z000000001 - CAVITY ACCESS Z SET: 2022-11-28 Endodontic Instrument
• J003C0321000208001 - Unimetric T Demo Kit: 2022-11-28 Endodontic Posts Set
• J003C0321000210001 - Unimetric T Demo Kit: 2022-11-28 Endodontic Posts Set
• J003D0028140007001 - Steel burs cavity cylindric round: 2022-11-28 STEEL BURS CYL. ROUND HP 007
• J003D0028140010001 - Steel burs cavity cylindric round: 2022-11-28 STEEL BURS CYL. ROUND HP 010