FDA.reportPublic FDA data

Guide Wheel Guide Pole

Primary DI
08800053004688
Brand
Guide Wheel Guide Pole
Company
DENTIS CO. ,LTD
Model
DGWGPL
Device description
Dental Implant Instrument / Guide Wheel Guide Pole
Published
2021-06-02
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
08800053004688PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800053004688088000530046888800053004688

GMDN Terms#

Term, Definition table
TermDefinition
Dental implantation depth/angle gauge, reusableA device designed to be used during the planning and post-osteotomy stages of a dental implantation procedure, prior to surgical implant placement/fixation, to measure/determine various lengths (e.g., drill depth of the osteotomy cavity, mucosal height, distance between implants/teeth for determining the mesiodistal position of the implant) and/or angles [e.g., direction of the perforation in relation to the antagonist arch], typically to help select an appropriate final prosthetic abutment to be installed. It is typically graduated and may be a hand-held instrument or a stand-alone device placed intraorally; some types are intended for use during x-ray imaging. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
694721181
Device count
1
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
08800313235449Guide Anchor PinDGAP142026-08-19
08800313235456Guide Bone AnchorDGBA132026-08-19
08800313235463Guide Bone AnchorDGBA112026-08-19
08800313235470Guide Bone AnchorDGBA092026-08-19
08800313235487Guide Fixture AnchorDGFAN132026-08-19
08800313235494Guide Fixture AnchorDGFAM132026-08-19
08800313235500Guide Fixture AnchorDGFAR132026-08-19
08800313235517Guide Fixture AnchorDGFAN112026-08-19
08800313235524Guide Fixture AnchorDGFAM112026-08-19
08800313235531Guide Fixture AnchorDGFAR112026-08-19
08800313235548Guide Fixture AnchorDGFAN092026-08-19
08800313235555Guide Fixture AnchorDGFAM092026-08-19
08800313235562Guide Fixture AnchorDGFAR092026-08-19
08800313235715SQ AXEL Guide CountersinkDSAGCS502026-07-09
08800313235722SQ AXEL Guide CountersinkDSAGCS462026-07-09
08800313235739SQ AXEL Guide CountersinkDSAGCS422026-07-09
08800313235746SQ AXEL Guide CountersinkDSAGCS382026-07-09
08800313235753SQ AXEL Guide Step DrillDSAGSTD50162026-07-09
08800313235760SQ AXEL Guide Step DrillDSAGSTD50142026-07-09
08800313235777SQ AXEL Guide Step DrillDSAGSTD50122026-07-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800313235449Guide Anchor PinDENTIS CO. ,LTDNDP2026-08-19
08800313235456Guide Bone AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235463Guide Bone AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235470Guide Bone AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235487Guide Fixture AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235494Guide Fixture AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235500Guide Fixture AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235517Guide Fixture AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235524Guide Fixture AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235531Guide Fixture AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235548Guide Fixture AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235555Guide Fixture AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235562Guide Fixture AnchorDENTIS CO. ,LTDNDP2026-08-19
04260516875448SIC invent Dental Implant SystemsSIC invent AGNDP2026-08-18
04260516875455SIC invent Dental Implant SystemsSIC invent AGNDP2026-08-18
04260516875462SIC invent Dental Implant SystemsSIC invent AGNDP2026-08-18
04260516875479SIC invent Dental Implant SystemsSIC invent AGNDP2026-08-18
04260516878197SIC invent Dental Implant SystemsSIC invent AGNDP2026-08-18
07290108810639Plastic Castable AbutmentNORIS MEDICAL LTDNDP2026-08-18
07290108810646Plastic Castable AbutmentNORIS MEDICAL LTDNDP2026-08-18
07290108810653Plastic Castable AbutmentNORIS MEDICAL LTDNDP2026-08-18
07290108810684Plastic Castable AbutmentNORIS MEDICAL LTDNDP2026-08-18
07290108810691Plastic Castable AbutmentNORIS MEDICAL LTDNDP2026-08-18
07290108810707Plastic Castable AbutmentNORIS MEDICAL LTDNDP2026-08-18
07290108810714Plastic Castable AbutmentNORIS MEDICAL LTDNDP2026-08-18
07290108810721Plastic Castable AbutmentNORIS MEDICAL LTDNDP2026-08-18
07290108810738Plastic Castable AbutmentNORIS MEDICAL LTDNDP2026-08-18
07290108810745Plastic Castable AbutmentNORIS MEDICAL LTDNDP2026-08-18
07290108810752Plastic Castable AbutmentNORIS MEDICAL LTDNDP2026-08-18
07290108810769Plastic Castable AbutmentNORIS MEDICAL LTDNDP2026-08-18