Prima 45001K

GUDID D76845001K0

Healing Cap

KEYSTONE DENTAL, INC.

Dental implant suprastructure, temporary, preformed, single-use

• Primary Device ID: D76845001K0
• NIH Device Record Key: 9d284e97-bdc4-4688-a7cd-c0f8c74335f3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Prima
• Version Model Number: 45001K
• Catalog Number: 45001K
• 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	D76845001K0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K050506

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: 2016-02-04

On-Brand Devices [Prima]

• 453D76803K0: Zi Coping
• D768L170201K0: Ratchet
• D768L1407K0: Conversion Handle
• D768L140401K0: Extender
• D768ISS1112K0: Conversion Handle
• D768ISS1111K0: Driver O-Ring
• D768ISS1102K0: Wrench
• D768ISS1101K0: Wrench
• D768ISS1100K0: Wrench
• D768E401000: Anchor Pin
• D768E201010: Drill
• D76845967K0: MultiUnit Abutment
• D76845966K0: MultiUnit Abutment
• D76845965K0: MultiUnit Abutment
• D76845924K0: Quad Driver
• D76845311K0: Reamer
• D76845293K0: Quad Driver
• D76845045K0: Parallel Pin
• D76845041K0: Abutment Try-In Set
• D76840007K0: Snap Seating Tool
• D76815778K0: Bone Profiler
• D76815721K0: Implant Driver
• D76815720K0: Implant Driver
• D76815686K0: Adapter
• D76815685K0: Implant Driver
• D76815684K0: Implant Driver
• D76815683K0: Implant Driver
• D76815682K0: Drill Guide
• D76815681K0: Drill Guide
• D76815680K0: Drill Guide
• D76815679K0: Drill
• D76815678K0: Drill
• D76815676K0: Drill
• D76815675K0: Drill
• D76815674K0: Drill
• D76815673K0: Tissue Punch
• D76815672K0: Tissue Punch
• D76815671K0: Tissue Punch
• D76815670K0: Tap
• D76815669K0: Tap
• D76815668K0: Tap
• D76815667K0: Tap
• D76815665K0: Tap
• D76815664K0: Tap
• D76815663K0: Drill
• D76815662K0: Drill
• D76815661K0: Drill
• D76815660K0: Drill
• D76815659K0: Drill
• D76815658K0: Drill