CAVITY ACCESS SET A030500000000

GUDID J003A0305000000001

Endodontic Instrument

MAILLEFER INSTRUMENTS HOLDING Sàrl

Carbide dental bur, reusable

• Primary Device ID: J003A0305000000001
• NIH Device Record Key: 98f32320-5279-443b-8128-a3c195a5e693
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CAVITY ACCESS SET
• Version Model Number: A030500000000
• Catalog Number: A030500000000
• 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	J003A0305000000001 [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: 2022-11-28Endodontic Instrument
• J003A0305000000001 - CAVITY ACCESS SET: 2022-11-28 Endodontic 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