FDA.reportPublic FDA data

CeraRoot Accessory for Surgery

Primary DI
08054754742589
Brand
CeraRoot Accessory for Surgery
Company
SAEG SRL
Model
Non-invasive
Catalog number
005.017-S
Device description
Transporter / driver 16 short steel
Published
2025-05-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08054754742589PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08054754742589080547547425898054754742589

GMDN Terms#

Term, Definition table
TermDefinition
Surgical screwdriver, reusableA non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
439714379
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08054754742572CeraRoot Accessory for SurgeryNon-invasive005.016-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
08054754740127CeraRoot Guided InstrumentsSurgically invasive instrumentsFAB-1687/072023-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800016100686Dental Implants Accesseories-Single UseCowellmedi Co.,LtdNDP2026-08-03
08800016108774Dental Implants Accesseories-ReusableCowellmedi Co.,LtdNDP2026-07-28
08800076476271T-Marker KitTruabutment Korea Co.,LtdNDP2026-07-27
D7702682153RIGHT ANGLE SCREWDRIVER FORSWEDEN & MARTINA SPANDP2026-07-27
D7702698973DRILLSWEDEN & MARTINA SPANDP2026-07-27
D7702698983DRILLSWEDEN & MARTINA SPANDP2026-07-27
D7702750843INTRAORAL SCANBODYSWEDEN & MARTINA SPANDP2026-07-27
D7702750853INTRAORAL SCANBODYSWEDEN & MARTINA SPANDP2026-07-27
03701045246374KONTACTBIOTECH DENTALNDP2026-07-24
03701045246381KontactBIOTECH DENTALNDP2026-07-24
08800076470569HS Cap SmallTruabutment Korea Co.,LtdNDP2026-07-21
08800076475830T-L Digital AnalogTruabutment Korea Co.,LtdNDP2026-07-21
08800076476042T-Marker KitTruabutment Korea Co.,LtdNDP2026-07-21
08800076476059T-MarkerTruabutment Korea Co.,LtdNDP2026-07-21
08800076476066T-MarkerTruabutment Korea Co.,LtdNDP2026-07-21
08800076476073T-MarkerTruabutment Korea Co.,LtdNDP2026-07-21
08800076476080T-MarkerTruabutment Korea Co.,LtdNDP2026-07-21
08800076476097T-MarkerTruabutment Korea Co.,LtdNDP2026-07-21
08800076476103T-MarkerTruabutment Korea Co.,LtdNDP2026-07-21
08800076476110T-MarkerTruabutment Korea Co.,LtdNDP2026-07-21
08800076476127T-MarkerTruabutment Korea Co.,LtdNDP2026-07-21
08800076476134T-MarkerTruabutment Korea Co.,LtdNDP2026-07-21
08800076476141T-MarkerTruabutment Korea Co.,LtdNDP2026-07-21
08800076476172T-Marker ScrewTruabutment Korea Co.,LtdNDP2026-07-21
08800076476219TruBite ScopeTruabutment Korea Co.,LtdNDP2026-07-21
08800076476226TruBoltTruabutment Korea Co.,LtdNDP2026-07-21
08800076476233TruBoltTruabutment Korea Co.,LtdNDP2026-07-21
08435673515131DYNAMIC ABUTMENT SOLUTIONSTALLADIUM ESPAÑA SLNDP2026-07-20
07899995235299DRIVER HANDPIECE MINI ABUT. EXT. LONGSin Sistema de Implante Nacional S/ANDP2026-07-14
07899995235305DRIVER HANDPIECE MINI ABUT. LONGSin Sistema de Implante Nacional S/ANDP2026-07-14