CAVITY ACCESS Z SET A305Z00000000

GUDID J003A305Z000000001

Endodontic Instrument

MAILLEFER INSTRUMENTS HOLDING Sàrl

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

• J003TNSRMGPF000200 - Reciproc Minima: 2025-09-22 Reciproc Minima ConformFit Gutta Percha Point R20
• J003TNSRMGPF000250 - Reciproc Minima: 2025-09-22 Reciproc Minima ConformFit Gutta Percha Point R25
• J003TNSRMGPF000350 - Reciproc Minima: 2025-09-22 Reciproc Minima ConformFit Gutta Percha Point R35
• J003TNSRMGPF000450 - Reciproc Minima: 2025-09-22 Reciproc Minima ConformFit Gutta Percha Point R45
• J003TNSRMGPF00AST0 - Reciproc Minima: 2025-09-22 Reciproc Minima ConformFit Gutta Percha Point Assortment (12x20, 24x25, 12x 35, 12x45)
• J003E055034102B001 - CF: 2025-09-19 Dental burs
• J003TSTRMPPM00AST1 - Reciproc Minima: 2025-08-13 Reciproc Minima Paper Points Assortment (30x20, 90x25, 30x 35, 30x45)
• J003TDDRCPM621AST1 - Reciproc Minima: 2025-07-30 DEMO -Reciproc Minima Assortment (2x20, 2x25, 1x 35, 1x45), 21mm