FDA.reportPublic FDA data

DRILL Ø3,3MM GUIDED

Primary DI
07899995276667
Brand
DRILL Ø3,3MM GUIDED
Company
Sin Sistema de Implante Nacional S/A
Model
FHIG 33
Device description
DRILL Ø3,3MM GUIDED
Published
2023-08-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
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
07899995276667PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07899995276667078999952766677899995276667

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
904569092
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07899995235541RATCHET RETRIEVER DRIVER M1.6 MEDIUMCCER 16MCCER 16M2026-06-23
07899995279668Abutment ScrewPRH 30 PACK4PRH 30 PACK42026-03-13
07899995243805DRIVER RATCHET HEX1.4 EXT. LONG ANG.CCH 1437ACCH 1437A2025-12-23
07899995243812DRIVER RATCHET HEX1.4 LONG ANG.CCH 1430ACCH 1430A2025-12-23
07899995243829DRIVER RATCHET HEX1.4 MEDIUM ANG.CCH 1424ACCH 1424A2025-12-23
07899995243836DRIVER RATCHET HEX1.4 SHORT ANG.CCH 1420ACCH 1420A2025-12-23
07899995243843DRIVER HANDP. HEX.1.4MM EXT. LONG ANG.CTH 1437ACTH 1437A2025-12-23
07899995243850DRIVER HANDPIECE HEX.1.4MM LONG ANG.CTH 1430ACTH 1430A2025-12-23
07899995243874DRIVER HANDPIECE HEX.1.4MM MEDIUM ANG.CTH 1424ACTH 1424A2025-12-23
07899995243881DRIVER HANDPIECE HEX.1.4MM SHORT ANG.CTH 1420ACTH 1420A2025-12-23
07899995240507DIRECTION INDICATOR ANGLED 52°IDA 52IDA 522025-11-26
07899995241108BioHorizonsZPK4500ZPK45002025-11-25
07899995243140BioHorizonsZPMDZPMD2025-11-25
07899995243157BioHorizonsZDPZDP2025-11-25
07899995243164BioHorizonsSTW80STW802025-11-25
07899995243225BioHorizonsHD050RHD050R2025-11-25
07899995243232BioHorizonsHD050MHD050M2025-11-25
07899995243263BioHorizonsHD050HHD050H2025-11-25
07899995243270BioHorizonsCRTRY60CRTRY602025-11-25
07899995243287BioHorizonsCRTRY52CRTRY522025-11-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800313235715SQ AXEL Guide CountersinkDENTIS CO. ,LTDNDP2026-07-09
08800313235722SQ AXEL Guide CountersinkDENTIS CO. ,LTDNDP2026-07-09
08800313235739SQ AXEL Guide CountersinkDENTIS CO. ,LTDNDP2026-07-09
08800313235746SQ AXEL Guide CountersinkDENTIS CO. ,LTDNDP2026-07-09
08800313235753SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235760SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235777SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235784SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235791SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235807SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235814SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235821SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235838SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235845SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235852SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235869SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235876SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235883SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235890SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235906SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235913SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235920SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235937SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235944SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235951SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235968SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235975SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235982SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235999SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313236002SQ Guide Long DrillDENTIS CO. ,LTDNDP2026-07-09