FDA.reportPublic FDA data

CeraRoot Guided Instruments

Primary DI
08053610296488
Brand
CeraRoot Guided Instruments
Company
SAEG SRL
Model
Surgically invasive instruments
Catalog number
FAB-0340/06D
Device description
Cilindrical Drill 4,3mm DLC
Published
2023-10-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
08053610296488PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08053610296488080536102964888053610296488

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.

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
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
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
06947600329107Driver,BLT,Adapter,for handpiece,for tap,L25mm,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600329572Driver,BL/BLT,Adapter,for handpiece,L25mm,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600329909Driver,BL/BLT,NoMount Driver,NC,short,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600329923Driver,BL/BLT,NoMount Driver,RC,short,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600330691Tap,BLT,Φ3.3mm,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600330707Tap,BLT,Φ4.1mm,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600330714Tap,BLT,Φ4.8mm,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600330721Template Fixation Pin,Φ1.35mmBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600330738Driver,NoMount Torque Driver,NC,Middle,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600330745Driver,NoMount Torque Driver,RC,Middle,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
08059224214320OT EQUATORRHEIN 83 SRLNDP2026-05-27
08059224214344OT EQUATORRHEIN 83 SRLNDP2026-05-27
08435389830160SHORT POSITIONER FOR UNIVERSAL PLUS PLATFORM (2 UNITS)BIOTECHNOLOGY INSTITUTE SLNDP2026-05-27
08435389830177UNIVERSAL PLUS PLATFORM POSITIONER (2 UNITS)BIOTECHNOLOGY INSTITUTE SLNDP2026-05-27
08435389830443SURGICAL GUIDE TEMPORARY BALL ATTACHMENT; MULTI-IM; Ø4,1 mmBIOTECHNOLOGY INSTITUTE SLNDP2026-05-27
EMKA013529MEDENTiKAMEDENTiKA GmbHNDP2020-04-30
EMKA005039MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013049MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013059MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013189MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013229MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013239MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013289MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013369MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013379MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013389MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013399MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013509MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013599MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013609MEDENTiKAMEDENTiKA GmbHNDP2020-04-08