Spectra-Cone Abutment

GUDID 00889024017078

ZIMMER DENTAL INC.

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 00889024017078
• NIH Device Record Key: 075200be-fe8c-4aa5-97b3-86228d931dec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Spectra-Cone Abutment
• Version Model Number: SCGCH
• Company DUNS: 103167086
• Company Name: ZIMMER DENTAL INC.
• Device Count: 1
• DM Exempt: true
• 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: false
• 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

Customer Support Contacts

• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024017078 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K011028

FDA Product Code

• DZE: IMPLANT, ENDOSSEOUS, ROOT-FORM

Sterilization

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

[00889024017078]

Moist Heat or Steam Sterilization

[00889024017078]

Moist Heat or Steam Sterilization

[00889024017078]

Moist Heat or Steam Sterilization

[00889024017078]

Moist Heat or Steam Sterilization

[00889024017078]

Moist Heat or Steam Sterilization

[00889024017078]

Moist Heat or Steam Sterilization

[00889024017078]

Moist Heat or Steam Sterilization

[00889024017078]

Moist Heat or Steam Sterilization

[00889024017078]

Moist Heat or Steam Sterilization

[00889024017078]

Moist Heat or Steam Sterilization

[00889024017078]

Moist Heat or Steam Sterilization

[00889024017078]

Moist Heat or Steam Sterilization

[00889024017078]

Moist Heat or Steam Sterilization

[00889024017078]

Moist Heat or Steam Sterilization

[00889024017078]

Moist Heat or Steam Sterilization

[00889024017078]

Moist Heat or Steam Sterilization

[00889024017078]

Moist Heat or Steam Sterilization

[00889024017078]

Moist Heat or Steam Sterilization

[00889024017078]

Moist Heat or Steam Sterilization

[00889024017078]

Moist Heat or Steam Sterilization

[00889024017078]

Moist Heat or Steam Sterilization

[00889024017078]

Moist Heat or Steam Sterilization

[00889024017078]

Moist Heat or Steam Sterilization

[00889024017078]

Moist Heat or Steam Sterilization

[00889024017078]

Moist Heat or Steam Sterilization

[00889024017078]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-11-08
• Device Publish Date: 2015-10-23

On-Brand Devices [Spectra-Cone Abutment]

• 00889024017436: SPH20
• 00889024017115: SCTT
• 00889024017078: SCGCH
• 00889024017061: SCGC
• 00889024017054: SCDTS