FDA.reportPublic FDA data

CeraRoot Implant System

Primary DI
08435453900300
Brand
CeraRoot Implant System
Company
CERAROOT SL.
Model
002.002
Catalog number
002.002
Device description
Twist Drill 2.3mm cylindrical, with laser marks at 6-8-10-12-14-16mm. Made of Ceramic.
Published
2019-09-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DZIDrill, Bone, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZIDrill, Bone, PoweredDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K093595000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K093595000CERAROOT IMPLANT SYSTEMOral Iceberg S.L.2011-01-04DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08435453900300PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08435453900300084354539003008435453900300

GMDN Terms#

Term, Definition table
TermDefinition
Fixture/appliance dental drill bit, reusableA shaft of metal intended to be used in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavity to facilitate the implantation of a dental fixture/appliance. The device is typically available in a set of graduated sizes and various forms and functions (e.g., guide, pilot, twist, cortical, conical). It is attached to a manual or power tool handpiece that provides rotation. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter2.3Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+18184504776usa@ceraroot.com
+34937683962info@ceraroot.com

Regulatory Flags#

DUNS number
467001948
Device count
1
DM exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08435453900515CeraRoot Implant System005.214005.2142019-09-15
08435453901086CeraRoot Implant System006.111006.1112025-04-27
08435453901222CeraRoot Implant System120.008120.0082025-04-27
08435453901093CeraRoot Guided Surgery System020.002S020.02S2023-11-06
08435453900737CeraRoot Implant System020.002020.0022023-11-02
08435453900355CeraRoot Implant System001.007001.0072019-09-14
08435453900256CeraRoot Implant System001.001001.0012019-08-29
08435453900263CeraRoot Implant System001.002001.0022019-08-29
08435453900287CeraRoot Implant System001.004001.0042019-09-14
08435453900294CeraRoot Implant System001.005001.0052019-09-14
08435453900317CeraRoot Implant System002.003002.0032019-09-14
08435453900324CeraRoot Implant System002.004002.0042019-09-14
08435453900331CeraRoot Implant System002.005002.0052019-09-14
08435453900362CeraRoot Implant System003.016003.0162019-09-14
08435453900379CeraRoot Implant System003.011003.0112019-09-14
08435453900386CeraRoot Implant System003.021003.0212019-09-14
08435453900393CeraRoot Implant System003.014003.0142019-09-14
08435453900409CeraRoot Implant System004.016004.0162019-09-14
08435453900416CeraRoot Implant System004.011004.0112019-09-14
08435453900423CeraRoot Implant System004.021004.0212019-09-14

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