FDA.reportPublic FDA data

GUIDED INITIAL DRILL Ø2.0X5MM

Primary DI
07899995234636
Brand
GUIDED INITIAL DRILL Ø2.0X5MM
Company
Sin Sistema de Implante Nacional S/A
Model
FICG 2005
Catalog number
FICG 2005
Device description
GUIDED INITIAL DRILL Ø2.0X5MM
Published
2026-10-30
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

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
07899995234636PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07899995234636078999952346367899995234636

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
904569092
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07899995226273DRIVET RATCHET IMP. CM GUIDED MOD. 02CCCMG 02CCCMG 022026-10-30
07899995226280DRIVER RATCHET IMP. CM GUI. EST. MOD. 02CCCMG 02ECCCMG 02E2026-10-30
07899995226297DRIVER RATCHET IMP. CM GUIDEDCCCMG 01CCCMG 012026-10-30
07899995226303DRIVER RATCHET IMP. CM GUIDED NARROWCCCMG 01ECCCMG 01E2026-10-30
07899995226327DRIVER C.A. IMP. CM GUIDED NARROWCTCMG 01ECTCMG 01E2026-10-30
07899995226587FIX. SURGICAL GUIDE PALATAL Ø2.0MMFGPMT 20FGPMT 202026-10-30
07899995234315DEPTH PROBE GUIDED MOD. 02SPG 02SPG 022026-10-30
07899995234384HELICAL DRILL Ø1.4MMFHDG 14FHDG 142026-10-30
07899995234629GUIDED INITIAL DRILL Ø2.0X9MMFICG 2009FICG 20092026-10-30
07899995234643GUIDED INITIAL DRILL Ø2.0X9MM EST.FICG 2009EFICG 2009E2026-10-30
07899995234674GUIDED INITIAL DRILL Ø2.0X5MM EST.FICG 2005EFICG 2005E2026-10-30
07899995234681COUNTERBORE DRILL GUIDED Ø4.8MMFPLG 48FPLG 482026-10-30
07899995234698GUIDED INITIAL DRILL Ø4.2MMFPLG 42FPLG 422026-10-30
07899995234704GUIDED INITIAL DRILL Ø3.5MM EST.FPLG 35EFPLG 35E2026-10-30
07899995234766CONICAL DRILL GUI. Ø3.8/4.0X13MMFRCVG 3813FRCVG 38132026-10-30
07899995234773CONICAL DRILL GUI. Ø5.0X15MMFRCVG 5015FRCVG 50152026-10-30
07899995234780CONICAL DRILL GUI. Ø5.0X13MMFRCVG 5013FRCVG 50132026-10-30
07899995234797CONICAL DRILL GUI. Ø5.0X11.5MMFRCVG 5011FRCVG 50112026-10-30
07899995234803CONICAL DRILL GUI. Ø5.0X10MMFRCVG 5010FRCVG 50102026-10-30
07899995234810CONICAL DRILL GUI. Ø5.0X8.5MMFRCVG 5085FRCVG 50852026-10-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800076476356TruBite ScopeTruabutment Korea Co.,LtdNDP2026-11-03
08800076476486TruBoltTruabutment Korea Co.,LtdNDP2026-11-03
08800076476493TruBoltTruabutment Korea Co.,LtdNDP2026-11-03
08800076476509TruBoltTruabutment Korea Co.,LtdNDP2026-11-03
08800076476516TruBoltTruabutment Korea Co.,LtdNDP2026-11-03
07290109308654Single TMA Snap-On TransferADIN DENTAL IMPLANT SYSTEMS LTDNDP2026-11-01
07290116770031Depth Probe, Extra Long 16-25mmADIN DENTAL IMPLANT SYSTEMS LTDNDP2026-11-01
07290116770246Single TMA Digital Model Abutment Replica, MachinedADIN DENTAL IMPLANT SYSTEMS LTDNDP2026-11-01
07290116770314Guided UniFit Fixture Mount Screw Retained ScrewADIN DENTAL IMPLANT SYSTEMS LTDNDP2026-11-01
07290116770383IRIS™, Burnout anti rotation cap red (4 pack)ADIN DENTAL IMPLANT SYSTEMS LTDNDP2026-11-01
07290116770390IRIS™, Burnout cap white (4 pack)ADIN DENTAL IMPLANT SYSTEMS LTDNDP2026-11-01
07640169734823BiodentaBiodenta Swiss AGNDP2026-10-30
07640169736056BiodentaBiodenta Swiss AGNDP2026-10-30
07640169736063BiodentaBiodenta Swiss AGNDP2026-10-30
07640169736070BiodentaBiodenta Swiss AGNDP2026-10-30
07899995226273DRIVET RATCHET IMP. CM GUIDED MOD. 02Sin Sistema de Implante Nacional S/ANDP2026-10-30
07899995226280DRIVER RATCHET IMP. CM GUI. EST. MOD. 02Sin Sistema de Implante Nacional S/ANDP2026-10-30
07899995226297DRIVER RATCHET IMP. CM GUIDEDSin Sistema de Implante Nacional S/ANDP2026-10-30
07899995226303DRIVER RATCHET IMP. CM GUIDED NARROWSin Sistema de Implante Nacional S/ANDP2026-10-30
07899995226327DRIVER C.A. IMP. CM GUIDED NARROWSin Sistema de Implante Nacional S/ANDP2026-10-30
07899995226587FIX. SURGICAL GUIDE PALATAL Ø2.0MMSin Sistema de Implante Nacional S/ANDP2026-10-30
07899995234315DEPTH PROBE GUIDED MOD. 02Sin Sistema de Implante Nacional S/ANDP2026-10-30
07899995234384HELICAL DRILL Ø1.4MMSin Sistema de Implante Nacional S/ANDP2026-10-30
07899995234629GUIDED INITIAL DRILL Ø2.0X9MMSin Sistema de Implante Nacional S/ANDP2026-10-30
08050038833271RealGUIDE Surgical Instruments3DIEMME SRLNDP2026-06-30
08050038833745RealGUIDE Surgical Instruments3DIEMME SRLNDP2026-06-30
08050038833752RealGUIDE Surgical Instruments3DIEMME SRLNDP2026-06-30
08050038833769RealGUIDE Surgical Instruments3DIEMME SRLNDP2026-06-30
08050038833776RealGUIDE Surgical Instruments3DIEMME SRLNDP2026-06-30
08050038833783RealGUIDE Surgical Instruments3DIEMME SRLNDP2026-06-30