CeraRoot Implant System 005.214

GUDID 08435453900515

Impactor for implant CeraRoot 14. A metal hand-held manual surgical instrument designed to position the CeraRoot 14 into the alveolar bone. Its mode of application is by transmission of an impact force to drive the implant into its final position in the bone. The proximal end is a handle designed to absorb the impact from a surgical hammer or mallet. The distal end is shaped curved to conform to the implant shape and is made of PEEK. This is a reusable device.

CERAROOT SL.

Orthopaedic implant impactor
Primary Device ID08435453900515
NIH Device Record Keycb71cb77-6252-4dda-ba8c-588a80133b04
Commercial Distribution StatusIn Commercial Distribution
Brand NameCeraRoot Implant System
Version Model Number005.214
Catalog Number005.214
Company DUNS467001948
Company NameCERAROOT SL.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+18184504776
Emailusa@ceraroot.com
Phone+18184504776
Emailusa@ceraroot.com
Phone+18184504776
Emailusa@ceraroot.com
Phone+18184504776
Emailusa@ceraroot.com
Phone+18184504776
Emailusa@ceraroot.com
Phone+18184504776
Emailusa@ceraroot.com
Phone+18184504776
Emailusa@ceraroot.com
Phone+18184504776
Emailusa@ceraroot.com
Phone+18184504776
Emailusa@ceraroot.com
Phone+18184504776
Emailusa@ceraroot.com
Phone+18184504776
Emailusa@ceraroot.com
Phone+18184504776
Emailusa@ceraroot.com
Phone+18184504776
Emailusa@ceraroot.com
Phone+18184504776
Emailusa@ceraroot.com
Phone+18184504776
Emailusa@ceraroot.com
Phone+18184504776
Emailusa@ceraroot.com
Phone+18184504776
Emailusa@ceraroot.com
Phone+18184504776
Emailusa@ceraroot.com
Phone+18184504776
Emailusa@ceraroot.com

Device Identifiers

Device Issuing AgencyDevice ID
GS108435453900515 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZNInstruments, Dental Hand
NDPAccessories, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08435453900515]

Moist Heat or Steam Sterilization

[08435453900515]

Moist Heat or Steam Sterilization

[08435453900515]

Moist Heat or Steam Sterilization

[08435453900515]

Moist Heat or Steam Sterilization

[08435453900515]

Moist Heat or Steam Sterilization

[08435453900515]

Moist Heat or Steam Sterilization

[08435453900515]

Moist Heat or Steam Sterilization

[08435453900515]

Moist Heat or Steam Sterilization

[08435453900515]

Moist Heat or Steam Sterilization

[08435453900515]

Moist Heat or Steam Sterilization

[08435453900515]

Moist Heat or Steam Sterilization

[08435453900515]

Moist Heat or Steam Sterilization

[08435453900515]

Moist Heat or Steam Sterilization

[08435453900515]

Moist Heat or Steam Sterilization

[08435453900515]

Moist Heat or Steam Sterilization

[08435453900515]

Moist Heat or Steam Sterilization

[08435453900515]

Moist Heat or Steam Sterilization

[08435453900515]

Moist Heat or Steam Sterilization

[08435453900515]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-09-23
Device Publish Date2019-09-15

On-Brand Devices [CeraRoot Implant System]

08435453900249Implant CeraRoot 12:14/4.1 Size L= 14mm Indicated for UPPER LATERAL INCISORS AND LOWER IN
08435453900232Implant CeraRoot 12:12/4.1 Size L= 12mm Indicated for UPPER LATERAL INCISORS AND LOWER IN
08435453900225Implant CeraRoot 12:10/4.1 Size L= 10mm Indicated for UPPER LATERAL INCISORS AND LOWER IN
08435453900218Implant CeraRoot 34:14/4.1-4.8 Size L= 14mm Indicated for CANINES AND PREMOLARS LONG ABUT
08435453900201Implant CeraRoot 34:12/4.1-4.8 Size L= 12mm Indicated for CANINES AND PREMOLARS LONG ABUT
08435453900195Implant CeraRoot 34:10/4.1-4.8 Size L= 10mm Indicated for CANINES AND PREMOLARS LONG A
08435453900188Implant CeraRoot 34:8/4.1-4.8 Size L= 8mm Indicated for CANINES AND PREMOLARS LONG ABUTM
08435453900171Implant CeraRoot 34:14/4.1-4.8 Size L= 14mm Indicated for CANINES AND PREMOLARS SHORT ABU
08435453900164Implant CeraRoot 34:12/4.1-4.8 Size L= 12mm Indicated for CANINES AND PREMOLARS SHORT ABU
08435453900157Implant CeraRoot 34:10/4.1-4.8 Size L= 10mm Indicated for CANINES AND PREMOLARS SHORT ABU
08435453900140Implant CeraRoot 34:8/4.1-4.8 Size L= 8mm Indicated for CANINES AND PREMOLARS SHORT ABUTM
08435453900133Implant CeraRoot 14:14/3.5-4.8 Size L= 14mm Indicated for BICUSPIDS/PREMOLAR One-piece
08435453900126Implant CeraRoot 14:12/3.5-4.8 Size L= 12mm Indicated for BICUSPIDS/PREMOLAR One-piece zi
08435453900119Implant CeraRoot 14:10/3.5-4.8 Size L= 10mm Indicated for BICUSPIDS/PREMOLAR One-piece zi
08435453900102Implant CeraRoot 14:08/3.5-4.8 Size L= 08mm Indicated for BICUSPIDS/PREMOLAR One-piece zi
08435453900096Implant CeraRoot 21:14/4.1-4.8 Size L= 14mm Indicated for UPPER CENTRAL INCISORS AND CUSP
08435453900089Implant CeraRoot 21:12/4.1-4.8 Size L= 12mm Indicated for UPPER CENTRAL INCISORS AND CUSP
08435453900072Implant CeraRoot 21:10/4.1-4.8 Size L= 10mm Indicated for UPPER CENTRAL INCISORS AND CUSP
08435453900065Implant CeraRoot 11:14/4.8-6 Size L= 14mm Indicated for WIDE CENTRAL INCISORS AND CUSPIDS
08435453900058Implant CeraRoot 11:12/4.8-6 Size L= 12mm Indicated for WIDE CENTRAL INCISORS AND CUSPIDS
08435453900041Implant CeraRoot 11:10/4.8-6 Size L= 10mm Indicated for WIDE CENTRAL INCISORS AND CUSPIDS
08435453900034Implant CeraRoot 16:14/4.8-6.5 Size L= 14mm Indicated for MOLARS One-piece zirconia denta
08435453900027Implant CeraRoot 16:12/4.8-6.5 Size L= 12mm Indicated for MOLARS One-piece zirconia denta
08435453900010Implant CeraRoot 16:10/4.8-6.5 Size L= 10mm Indicated for MOLARS One-piece zirconia denta
08435453900270Twist Drill 2.8mm cylindrical, with laser marks at 6-8-10-12-14-16mm. Made of Steel.
08435453900645Steel Tweezers with ceramic tip, designed to facilitate grasping and manipulation of soft-tissue
08435453900638CeraRoot Surgical Case (empty). It's used to store all the necessary instruments to perform the
08435453900621CeraRoot® Torque Wrench adapter - steel (Thumbwheel with an inside connection of universa
08435453900614CeraRoot Surgical Torque Wrench Kit 35N - steel (this package includes the Adapter/Thumbwhee
08435453900607Nobel Biocare® Torque Wrench adapter - steel
08435453900591Straumann® Torque Wrench adapter - steel
08435453900577Transporter 34 - ceramic for the CeraRoot 34 implant
08435453900560Transporter 21 - ceramic for the CeraRoot 21 implant
08435453900553Transporter 12 - ceramic for the CeraRoot 12 implant
08435453900546Transporter 11 - ceramic for the CeraRoot 11 implant
08435453900539Transporter 16 Short - ceramic for the CeraRoot 16 implant
08435453900522Transporter 16 Long - ceramic for the CeraRoot 16 implant
08435453900515Impactor for implant CeraRoot 14. A metal hand-held manual surgical instrument designed to posit
08435453900508Surgical Mallet. Both ends of the head are covered by Teflon caps that are autoclavable. Length
08435453900492Transporter 34 - steel for the CeraRoot 34 implant
08435453900485Transporter 21 - steel for the CeraRoot 21 implant
08435453900478Transporter 12 - steel for the CeraRoot 12 implant
08435453900461Transporter 11 - steel for the CeraRoot 11 implant
08435453900454Transporter 16 Short - steel for the CeraRoot 16 implant
08435453900447Transporter 16 Long - steel for the CeraRoot 16 implant
08435453900430Countersink 14 - for the implants CeraRoot 14 and the CeraRoot 34 and 34L- orange and violet col
08435453900423Countersink 21 - for the implant CeraRoot 21 - red color coded - ceramic
08435453900416Countersink 11 - for the implant CeraRoot 11 - green color coded - ceramic
08435453900409Countersink 16 - for the implant CeraRoot 16 - black color coded - ceramic
08435453900393Countersink 14 - for the implants CeraRoot 14 and the CeraRoot 34 and 34L- orange and violet col
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