Healing Abutmment

GUDID D890HAH5040

Healing Abutment Hex 5.0mm H 4.5mm

SPIRALTECH SUPERIOR DENTAL IMPLANTS, INC.

Dental implant suprastructure, temporary, preformed, reusable Dental implant suprastructure, temporary, preformed, reusable

• Primary Device ID: D890HAH5040
• NIH Device Record Key: 59baa14b-1426-4b23-ae22-c9d1d286937d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Healing Abutmment
• Version Model Number: HAH504
• Company DUNS: 086863437
• Company Name: SPIRALTECH SUPERIOR DENTAL IMPLANTS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D890HAH5040 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170372

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[D890HAH5040]

Moist Heat or Steam Sterilization

[D890HAH5040]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-09-16
• Device Publish Date: 2019-09-06

Devices Manufactured by SPIRALTECH SUPERIOR DENTAL IMPLANTS, INC.

• D890HACNP3830 - Healing Abutment: 2019-09-16 Healing Abutment Conical NP 3.8mm H3mm
• D890HACNP3840 - Healing Abutment: 2019-09-16 Healing Abutment Conical NP 3.8mm H4.5mm
• D890HACNP3860 - Healing Abutment: 2019-09-16 Healing Abutment Conical HP 3.8mm H 6mm
• D890HACNP45040 - Healing Abutment: 2019-09-16 Healing Abutment Conical NP 4.5mm H 4.5mm
• D890HACNP4530 - Healing Abutment: 2019-09-16 Healing Abutment Conical NP 4.5mm H 3mm
• D890HACNP4560 - Healing Abutment: 2019-09-16 Healing Abutment Conicap NP 4.5mm H 6mm
• D890HACRP3830 - Healing Abutment: 2019-09-16 Healing Abutment Conical RP 3.8mm H 3mm
• D890HACRP3840 - Healing Abutment: 2019-09-16 Healing Abutment Conical RP 3.8mm H 4.5mm