FDA.reportPublic FDA data

Healing Abutment

Primary DI
08806388287017
Brand
Healing Abutment
Company
Megagen Implant Co. Ltd
Model
AOHM70805
Catalog number
AOHM70805T
Device description
AnyOne Internal & ST Implant System (M4) M/ M7/ L8/ H=5/ Hex
Published
2023-06-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
NHAAbutment, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NHAAbutment, Implant, Dental, EndosseousDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K210826000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K210826000Healing Abutment, Cover ScrewMegagen Implant Co., Ltd.2022-02-03NHA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08806388287017PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806388287017088063882870178806388287017

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant suprastructure, temporary, preformed, single-useA prefabricated device intended to be used during dental implant restorative and laboratory procedures to provide a temporary intermediate fixture level between a dental implant and a temporary dental prosthesis/restoration, during the oral soft-tissue healing and sculpturing period, prior to the fabrication/rehabilitation and installation of the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It typically includes burnout/temporary cylinders, fixture impression pick-ups, replica devices, caps/cover screws in a variety of shapes, sizes, and materials [e.g., titanium (Ti), plastic]. This is a single-use device.

Regulatory Flags#

DUNS number
687388178
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08806388277483Healing AbutmentAOHS50652NAOHS50652NT2023-06-08
08806388286973Healing AbutmentAOHM60907AOHM60907T2023-06-08
08806388286980Healing AbutmentAOHM70802AOHM70802T2023-06-08
08806388286997Healing AbutmentAOHM70803AOHM70803T2023-06-08
08806388287000Healing AbutmentAOHM70804AOHM70804T2023-06-08
08806388287024Healing AbutmentAOHM70807AOHM70807T2023-06-08
08806388287031Healing AbutmentAOHM70902AOHM70902T2023-06-08
08806388287048Healing AbutmentAOHM70903AOHM70903T2023-06-08
08806388287055Healing AbutmentAOHM70904AOHM70904T2023-06-08
08806388287062Healing AbutmentAOHM70905AOHM70905T2023-06-08
08806388287079Healing AbutmentAOHM70907AOHM70907T2023-06-08
08806388287086Healing AbutmentAOHM70102AOHM70102T2023-06-08
08806388287093Healing AbutmentAOHM70103AOHM70103T2023-06-08
0880638828710908806388287109AOHM70104AOHM70104T2023-06-08
08806388287116Healing AbutmentAOHM70105AOHM70105T2023-06-08
08806388287123Healing AbutmentAOHM70107AOHM70107T2023-06-08
08806388287130Healing AbutmentAOHM80902AOHM80902T2023-06-08
08806388287147Healing AbutmentAOHM80903AOHM80903T2023-06-08
08806388287154Healing AbutmentAOHM80904AOHM80904T2023-06-08
08806388287161Healing AbutmentAOHM80905AOHM80905T2023-06-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D990EK2A0Essentials Kit, 2 ArchSMART DENTURE CONVERSIONS, LLCNHA2026-07-13
07290114710411Healing CapCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-07-12
07290114712156Abutments-AnalogCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-07-12
07290114712613Titanium-basesCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-07-12
00842092184301PreatPreat CorporationNHA2025-12-22
00842092184370PreatPreat CorporationNHA2025-12-22
00842092184394PreatPreat CorporationNHA2025-07-24
D762MUA030500M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA031000M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA032000M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA033000M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA034000M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA0345HCM0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA0345TBM0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA0345VCM0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA035000M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA040500M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA041000M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA042000M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA043000M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA044000M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA045000M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA050500M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA051000M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA052000M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA053000M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA054000M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA055000M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762THS0300010Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762THS1635230Implant-OneImplant Logistics, Inc.NHA2024-12-06