FDA.report

CeraRoot Guided Instruments

Primary DI
08054754740172
Brand
CeraRoot Guided Instruments
Company
SAEG SRL
Model
Surgically invasive instruments
Catalog number
FAB-1687/12
Device description
Cylindrical drill 3,50x10 guided
Published
2023-10-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications

CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08054754740172PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08054754740172080547547401728054754740172

GMDN Terms

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.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
439714379
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
08054754742572CeraRoot Accessory for SurgeryNon-invasive005.016-S2025-05-05
08054754742589CeraRoot Accessory for SurgeryNon-invasive005.017-S2025-05-05
08054754741728CeraRoot Guided InstrumentsFAB-1877FAB-18772024-10-25
08054754741735CeraRoot Guided InstrumentsFAB-1878FAB-18782024-10-25
08053610291377CeraRoot Guided InstrumentsSurgically invasive instrumentsFIL-235C2023-10-24
08053610291384CeraRoot Guided InstrumentsSurgically invasive instrumentsFIL-235E2023-10-24
08053610291391CeraRoot Guided InstrumentsSurgically invasive instrumentsFIL-235L2023-10-24
08053610296433CeraRoot Guided InstrumentsSurgically invasive instrumentsFAB-0340/01D2023-10-24
08053610296440CeraRoot Guided InstrumentsSurgically invasive instrumentsFAB-0340/02D2023-10-24
08053610296457CeraRoot Guided InstrumentsSurgically invasive instrumentsFAB-0340/03D2023-10-24
08053610296464CeraRoot Guided InstrumentsSurgically invasive instrumentsFAB-0340/04D2023-10-24
08053610296471CeraRoot Guided InstrumentsSurgically invasive instrumentsFAB-0340/05D2023-10-24
08053610296488CeraRoot Guided InstrumentsSurgically invasive instrumentsFAB-0340/06D2023-10-24
08053610296495CeraRoot Guided InstrumentsSurgically invasive instrumentsFAB-0340/07D2023-10-24
08054754740066CeraRoot Guided InstrumentsSurgically invasive instrumentsFAB-1687/012023-10-24
08054754740073CeraRoot Guided InstrumentsSurgically invasive instrumentsFAB-1687/022023-10-24
08054754740080CeraRoot Guided InstrumentsSurgically invasive instrumentsFAB-1687/032023-10-24
08054754740097CeraRoot Guided InstrumentsSurgically invasive instrumentsFAB-1687/042023-10-24
08054754740103CeraRoot Guided InstrumentsSurgically invasive instrumentsFAB-1687/052023-10-24
08054754740110CeraRoot Guided InstrumentsSurgically invasive instrumentsFAB-1687/062023-10-24

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