Implanova

GUDID 00858809005005

DENTAL EVOLUTIONS, INC

Dental implant system

• Primary Device ID: 00858809005005
• NIH Device Record Key: 79107dec-8b57-479c-912b-320e4af88c64
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Implanova
• Version Model Number: IB3510
• Company DUNS: 065079164
• Company Name: DENTAL EVOLUTIONS, INC
• 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: 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858809005005 [Primary]

FDA Product Code

• DZE: Implant, Endosseous, Root-Form

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-07-05

On-Brand Devices [Implanova]

• 00858809005630: IB5506
• 00858809005623: IB4506
• 00858809005616: IB4514
• 00858809005098: IB5512
• 00858809005081: IB5510
• 00858809005074: IB5508
• 00858809005050: IB4512
• 00858809005043: IB4510
• 00858809005036: IB4508
• 00858809005029: IB3514
• 00858809005012: IB3512
• 00858809005005: IB3510
• 00858809005197: IB5512
• 00860009618077: IB5514
• 00860009618022: IB6506
• 00860009618015: IB7506
• 00860009618008: IB8506
• 00860007860515: IB8508
• 00860007860508: IB7510
• 00860001466843: IB3508
• 00860001466829: IB6508
• 00858809005814: IB3010
• 00858809005067: IB7508
• 00850062839120: IB8510
• 00860009618091: IT4014
• 00860009618084: IT4012
• 00860009618053: 30FG
• 00860009618046: AB20SP
• 00860007860577: TLAB
• 00860001466850: AB155P
• 00860001466805: RAB
• 00858809005968: CAWL
• 00858809005951: CAWM
• 00858809005944: CAWS
• 00858809005937: CASL
• 00858809005920: CASM
• 00858809005913: CASS
• 00858809005890: CANL
• 00858809005883: CANM
• 00858809005876: CANS
• 00858809005548: ABSWL
• 00858809005531: ABSSL
• 00858809005524: ABSNL
• 00858809005517: ABSNM
• 00858809005487: ABSSM
• 00858809005470: ABSWM
• 00858809005463: ABNSS
• 00858809005456: ABNWS
• 00858809005203: ABNNP
• 00008588095357: ABSCR