FDA.reportPublic FDA data

Impression Coping

Primary DI
08800292994900
Brand
Impression Coping
Company
Megagen Implant Co. Ltd
Model
AANITH6012HT
Catalog number
AANITH6012HT
Device description
Ø5/ H=4
Published
2025-09-25
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
08800292994900PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800292994900088002929949008800292994900

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
687388178
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08806388266173ZrGEN AbutmentARZXM503825ARZXM503825.MTN2024-01-31
08806388244812ZrGEN AbutmentARZXM5015ARZXM5015.MTN2023-06-22
08806388244829ZrGEN AbutmentARZXM5525ARZXM5525.MTN2023-06-22
08806388244836ZrGEN AbutmentARZXM5016ARZXM5016.MTN2023-06-22
08806388244843ZrGEN AbutmentARZXM5526ARZXM5526.MTN2023-06-22
08806388244850ZrGEN AbutmentARZXM5015NARZXM5015N.MTN2023-06-22
08806388244867ZrGEN AbutmentARZXM5525NARZXM5525N.MTN2023-06-22
08806388244874ZrGEN AbutmentARZXM5016NARZXM5016N.MTN2023-06-22
08806388244898ZrGEN AbutmentARZXL5515ARZXL5515.MTN2023-06-22
08806388244904ZrGEN AbutmentARZXL6025ARZXL6025.MTN2023-06-22
08806388244911ZrGEN AbutmentARZXL5516ARZXL5516.MTN2023-06-22
08806388244928ZrGEN AbutmentARZXL6026ARZXL6026.MTN2023-06-22
08806388244935ZrGEN AbutmentARZXL5515NARZXL5515N.MTN2023-06-22
08806388244942ZrGEN AbutmentARZXL6025NARZXL6025N.MTN2023-06-22
08806388244959ZrGEN AbutmentARZXL5516NARZXL5516N.MTN2023-06-22
08806388244966ZrGEN AbutmentARZXL6026NARZXL6026N.MTN2023-06-22
08806388256624ZrGEN AbutmentAROZGN4015AROZGN4015T2023-06-22
08806388256631ZrGEN AbutmentAROZGN4025AROZGN4025T2023-06-22
08806388256648ZrGEN AbutmentAROZGR4515AROZGR4515T2023-06-22
08806388256655ZrGEN AbutmentAROZGR4525AROZGR4525T2023-06-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
07899995235312DRIVER HANDPIECE MINI ABUT. MEDIUMSin Sistema de Implante Nacional S/ANDP2026-07-14
07899995235329DRIVER RATCHET ABUT. HEX 2MM EXT. LONGSin Sistema de Implante Nacional S/ANDP2026-07-14
07899995235343DRIVER RATCHET ABUT. HEX 2MM LONGSin Sistema de Implante Nacional S/ANDP2026-07-14
07899995235367DRIVER RATCHET ABUT. HEX 2MM MEDIUMSin Sistema de Implante Nacional S/ANDP2026-07-14
07899995235374DRIVER RATCHET ABUT. HEX 2MM SHORTSin Sistema de Implante Nacional S/ANDP2026-07-14
07899995235381DRIVER RATCHET ABUT. HEX 2MM EXT. SHORTSin Sistema de Implante Nacional S/ANDP2026-07-14
07899995235503DRIVER RATCHET RETRIVER M1.6MM LONGSin Sistema de Implante Nacional S/ANDP2026-07-14
07899995235510DRIVER RATCHET RETRIVER M1.8MM MEDIUMSin Sistema de Implante Nacional S/ANDP2026-07-14
07899995235527DRIVER RATCHET RETRIVER M1.8MM SHORTSin Sistema de Implante Nacional S/ANDP2026-07-14
07899995235534DRIVER RATCHET RETRIVER M1.6MM LONGSin Sistema de Implante Nacional S/ANDP2026-07-14