JDZygoma ZY43575:

GUDID 08056591012634

JDZygoma Ø 4.3 L 57.5

J DENTAL CARE SRL

Dental implant system

• Primary Device ID: 08056591012634
• NIH Device Record Key: a7947009-d5dc-4fc4-876c-08db2b964164
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: JDZygoma
• Version Model Number: JDZygoma Ø 4.3 L 57.5
• Catalog Number: ZY43575:
• Company DUNS: 428716597
• Company Name: J DENTAL CARE SRL
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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: +39059454255
• Email: a.grandi@jdentalcare.com
• Phone: +39059454255
• Email: a.grandi@jdentalcare.com
• Phone: +39059454255
• Email: a.grandi@jdentalcare.com
• Phone: +39059454255
• Email: a.grandi@jdentalcare.com
• Phone: +39059454255
• Email: a.grandi@jdentalcare.com
• Phone: +39059454255
• Email: a.grandi@jdentalcare.com
• Phone: +39059454255
• Email: a.grandi@jdentalcare.com
• Phone: +39059454255
• Email: a.grandi@jdentalcare.com
• Phone: +39059454255
• Email: a.grandi@jdentalcare.com
• Phone: +39059454255
• Email: a.grandi@jdentalcare.com
• Phone: +39059454255
• Email: a.grandi@jdentalcare.com
• Phone: +39059454255
• Email: a.grandi@jdentalcare.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08056591012634 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240143

FDA Product Code

• DZE: Implant, Endosseous, Root-Form

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-10-29
• Device Publish Date: 2024-10-21

On-Brand Devices [JDZygoma]

• 08055510177430: 60mm Depth Probe JDZygoma
• 08055510177423: 60mm Straight Depth Probe JDZygoma
• 08056591012634: JDZygoma Ø 4.3 L 57.5
• 08056591012627: JDZygoma Ø 4.3 L 55
• 08056591012610: JDZygoma Ø 3.9 L 57.5
• 08056591012603: JDZygoma Ø 3.9 L 55
• 08056591012597: JDZygoma Ø 3.9 L 52.5
• 08056591012580: JDZygoma Ø 3.9 L 50
• 08056591012573: JDZygoma Ø 3.9 L 47.5
• 08056591012566: JDZygoma Ø 3.9 L 45
• 08056591012559: JDZygoma Ø 3.9 L 42.5
• 08056591012542: JDZygoma Ø 3.9 L 40
• 08056591012535: JDZygoma Ø 3.9 L 37.5
• 08056591012528: JDZygoma Ø 3.9 L 35
• 08056591012511: JDZygoma Ø 3.9 L 30
• 08056591011286: Conical Abutment Angulated 52.5° H 5.0 JDEvolution Plus
• 08055510176877: JDZygoma Ø 4.3 L 52.5
• 08055510176860: JDZygoma Ø 4.3 L 50
• 08055510176853: JDZygoma Ø 4.3 L 47.5
• 08055510176846: JDZygoma Ø 4.3 L 45
• 08055510176839: JDZygoma Ø 4.3 L 42.5
• 08055510176822: JDZygoma Ø 4.3 L 40
• 08055510176815: JDZygoma Ø 4.3 L 37.5
• 08055510176808: JDZygoma Ø 4.3 L 35
• 08055510176792: JDZygoma Ø 4.3 L 30
• 08055510175085: Screw for 60° Angulated Conical Abutment JDEvolution Plus
• 08055510175078: Conical Abutment Angulated 60° H 5.0 JDEvolution Plus
• 08055510175061: Conical Abutment Angulated 45° H 4.5 JDEvolution Plus