Single Patient Flat Bottom Countersink Shaping Drill

GUDID 00844868052203

Single Patient Flat Bottom Countersink Shaping Drill 4.85mmD x 5mmL

BIOMET 3I, LLC

Fixture/appliance dental drill bit, single-use
Primary Device ID00844868052203
NIH Device Record Keyf280d793-d64b-4a3c-8750-becbfd848a34
Commercial Distribution StatusIn Commercial Distribution
Brand NameSingle Patient Flat Bottom Countersink Shaping Drill
Version Model NumberSPFCS485S
Company DUNS186127825
Company NameBIOMET 3I, LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-342-5454
Emaildentalcs@zimvie.com
Phone1-800-342-5454
Emaildentalcs@zimvie.com
Phone1-800-342-5454
Emaildentalcs@zimvie.com
Phone1-800-342-5454
Emaildentalcs@zimvie.com
Phone1-800-342-5454
Emaildentalcs@zimvie.com
Phone1-800-342-5454
Emaildentalcs@zimvie.com
Phone1-800-342-5454
Emaildentalcs@zimvie.com
Phone1-800-342-5454
Emaildentalcs@zimvie.com
Phone1-800-342-5454
Emaildentalcs@zimvie.com
Phone1-800-342-5454
Emaildentalcs@zimvie.com
Phone1-800-342-5454
Emaildentalcs@zimvie.com
Phone1-800-342-5454
Emaildentalcs@zimvie.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100844868052203 [Primary]

FDA Product Code

NDPAccessories, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-12-26
Device Publish Date2025-12-18

On-Brand Devices [Single Patient Flat Bottom Countersink Shaping Drill]

00844868052210Single Patient Flat Bottom Countersink Shaping Drill 4.85mmD x 6mmL
00844868052203Single Patient Flat Bottom Countersink Shaping Drill 4.85mmD x 5mmL
00844868052197Single Patient Flat Bottom Countersink Shaping Drill 3.85mmD x 6mmL
00844868052180Single Patient Flat Bottom Countersink Shaping Drill 3.85mmD x 5mmL

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