Stage-1

GUDID D768S11013516K0

Drill

KEYSTONE DENTAL, INC.

Fixture/appliance dental drill bit, reusable

• Primary Device ID: D768S11013516K0
• NIH Device Record Key: 09eb4a52-a93f-4158-acdf-ad13075966bf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Stage-1
• Version Model Number: S1101-35-16K
• Company DUNS: 787471015
• Company Name: KEYSTONE DENTAL, 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: false
• 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: true
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(781)328-3313
• Email: sshahid@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
• Phone: +1(866)902-9272
• Email: info@keystonedental.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D768S11013516K0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K072768

FDA Product Code

• DZA: DRILL, DENTAL, INTRAORAL

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-01-09
• Device Publish Date: 2019-05-08

On-Brand Devices [Stage-1]

• D768S2503K0: Abutment Try-In Set
• D768S2428K0: Abutment Driver
• D768S2427K0: Abutment Driver
• D768S242619K0: Abutment Driver
• D768S242613K0: Abutment Driver
• D768S24201K0: Abutment Driver
• D768S24191K0: Abutment Driver
• D768S2418191K0: Abutment Driver
• D768S2418131K0: Abutment Driver
• D768S1805K0: Placement Head
• D768S180355K0: Depth Gauge
• D768S180348K0: Depth Gauge
• D768S180342K0: Depth Gauge
• D768S180335K0: Depth Gauge
• D768S180328K0: Depth Gauge
• D768S1802K0: Depth Gauge
• D768S170103K0: Adapter
• D768S170102K0: Adapter
• D768S170101K0: Adapter
• D768S1700K0: Wrench
• D768S160101K0: Placement Head
• D768S15014816K0: Tap
• D768S15014810K0: Tap
• D768S15014116K0: Tap
• D768S15014110K0: Tap
• D768S15006310K0: Tap
• D768S15005516K0: Tap
• D768S15005510K0: Tap
• D768S15003316K0: Tap
• D768S15003310K0: Tap
• D768S140201K0: Stage-1 Driver
• D768S14013301K0: Drill
• D768S140003K0: Adapter
• D768S140002K0: Adapter
• D768S140001K0: Adapter
• D768S11015510K0: Drill
• D768S11014816K0: Drill
• D768S11014810K0: Drill
• D768S11014216K0: Drill
• D768S11014210K0: Drill
• D768S11013516K0: Drill
• D768S11013510K0: Drill
• D768S11012816K0: Drill
• D768S11012810K0: Drill
• D768S11012016K0: Drill
• D768S11012010K0: Drill
• D768S11005510K0: Drill
• D768S11004816K0: Drill
• D768S11004810K0: Drill
• D768S11004216K0: Drill