Stage 1 42011K

GUDID D76842011K0

Temp Sleeve

KEYSTONE DENTAL, INC.

Dental implant suprastructure, temporary, preformed, single-use

• Primary Device ID: D76842011K0
• NIH Device Record Key: a02f03a3-5923-47bc-acfc-1d9abcafaffd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Stage 1
• Version Model Number: 42011K
• Catalog Number: 42011K
• Company DUNS: 787471015
• Company Name: KEYSTONE 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(866)902-9272
• Email: info@keystonedental.com
• Phone: +1(866)902-9272
• Email: info@keystonedental.com
• Phone: +1(866)902-9272
• Email: info@keystonedental.com
• Phone: +1(866)902-9272
• Email: info@keystonedental.com
• Phone: +1(866)902-9272
• Email: info@keystonedental.com
• Phone: +1(866)902-9272
• Email: info@keystonedental.com
• Phone: +1(866)902-9272
• Email: info@keystonedental.com
• Phone: +1(866)902-9272
• Email: info@keystonedental.com
• Phone: +1(866)902-9272
• Email: info@keystonedental.com
• Phone: +1(866)902-9272
• Email: info@keystonedental.com
• Phone: +1(866)902-9272
• Email: info@keystonedental.com
• Phone: +1(866)902-9272
• Email: info@keystonedental.com
• Phone: +1(866)902-9272
• Email: info@keystonedental.com
• Phone: +1(866)902-9272
• Email: info@keystonedental.com
• Phone: +1(866)902-9272
• Email: info@keystonedental.com
• Phone: +1(866)902-9272
• Email: info@keystonedental.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D76842011K0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K003226

FDA Product Code

• NHA: ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2021-03-31
• Device Publish Date: 2018-01-18

On-Brand Devices [Stage 1]

• D768S2504K0: Preppable Abutment
• D768S2501701K0: COC Abutment
• D768S2501551K0: COC Abutment
• D768S2501401K0: COC Abutment
• D768S2435K0: Preppable Abutment
• D768S2432701K0: COC Abutment
• D768S2432551K0: COC Abutment
• D768S2432401K0: COC Abutment
• D768S24172K0: Oring Abutment
• D768S24170K0: Oring Abutment
• D768S2408K0: Abutment Screw
• D768S240501K0: Gold Sleeve
• D768S240500K0: Gold Sleeve
• D768S2400K0: Index Abutment
• D76842020K0: Snap Abutment
• D76842019K0: Snap Abutment
• D76842018K0: Snap Abutment
• D76842017K0: Snap Abutment
• D76842014K0: Abutment Screw
• D76842008K0: Gold Sleeve
• D76842007K0: Gold Sleeve
• D76842004K0: Index Abutment
• D76842002K0: Angled Abutment
• D76842001K: Angled Abutment
• D76842000K0: Abutment Screw
• D768S2506K0: Healing Cap
• D768S2439K0: Healing Cap
• D768S243570K0: Quick Cap
• D768S240701K0: Temp Sleeve
• D768S240700K0: Temp Sleeve
• D768S2401K0: Healing Cap
• D768S180645K0: Cover Screw
• D768S180630K0: Cover Screw
• D768S180045K0: Cover Screw
• D768S180030K0: Cover Screw
• D768S180015K0: Cover Screw
• D768S180000K0: Cover Screw
• D768S1800000: Cover Screw
• D76842026K0: Healing Cap
• D76842025K0: Healing Cap
• D76842024K0: Healing Cap
• D76842012K0: Temp Sleeve
• D76842011K0: Temp Sleeve
• D76842005K0: Healing Cap