FDA.reportPublic FDA data

NEXPLANT

Primary DI
08800024955636
Brand
NEXPLANT
Company
Achimhai Medical Corporation
Model
W-HA-6550
Device description
Wide Healing Abutment Ø6.5 / H=5.0mm
Published
2021-03-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
K142813000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142813000Biogensis Implant System-KissesBiogenesis Co., Ltd.2015-07-31DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800024955636PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800024955636088000249556368800024955636

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature1 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
694197900
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800024957579AIMGEN MAXAMA-3530AMA-3530-PA2022-07-05
08800024957586AIMGEN MAXKTA-MKTA-M-PA2022-07-05
08800024957593AIMGEN MAXATBA30ABA-3530-PA2022-07-05
08800024957609AIMGEN MAXTBD24SABD-24S-PA2022-07-05
08800024957616AIMGEN MAXTEDI20SAED-20S-PA2022-07-05
08800024957623AIMGEN MAXTEDI20LAED-20L-PA2022-07-05
08800024957630AIMGEN MAXATW-CNATW-CN-PA2022-07-05
08800024957647AIMGEN MAXKIT-MKIT-M-PA2022-07-05
08800024957654AIMGEN MAXAMS-15AMS-15-PA2022-07-05
08800024957661AIMGEN MAXAMS-25AMS-25-PA2022-07-05
08800024957678AIMGEN MAXAMS-35AMS-35-PA2022-07-05
08800024957685AIMGEN MAXKMDA351055HMDA-351055H-PA2022-07-05
08800024957692AIMGEN MAXKMDA351555HMDA-351555H-PA2022-07-05
08800024953908AIMGEN MAXATBA00ABA-3500-PA2022-04-05
08800024953915AIMGEN MAXATBA10ABA-3510-PA2022-04-05
08800024953922AIMGEN MAXATBA20ABA-3520-PA2022-04-05
08800024953939AIMGEN MAXBACABC-0-P2022-04-05
08800024953946AIMGEN MAXTBD24LABD-24L-PA2022-04-05
08800024953960AIMGEN MAXATBLAABL-00-P2022-04-05
08800024917641AIMGEN MAXATDA552570HADA-552570H-PA2022-03-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08435389830764MULTI-IM® HEALING CAP, TINY® & UNIVERSAL PLATFORM L:3 mmBIOTECHNOLOGY INSTITUTE SLNHA2026-05-27
00842092187661PreatPreat CorporationNHA2026-04-30
00842092187685PreatPreat CorporationNHA2026-04-30
00842092187708PreatPreat CorporationNHA2026-04-30
10841307135647Simply Iconic™ / InterActive™ DIRECTarch™ 3.0mmD Platform Straight MUA 1.5mmL CoIMPLANT DIRECT SYBRON MANUFACTURING LLCNHA2025-10-31
00842092122396Preat Implant ProstheticsPreat CorporationNHA2022-11-22
00842092125632PreatPreat CorporationNHA2022-10-24
00842092125656PreatPreat CorporationNHA2022-10-24
00842092126257PreatPreat CorporationNHA2022-10-24
00842092127001AstraPreat CorporationNHA2022-10-24
00842092127049AstraPreat CorporationNHA2022-10-24
00842092127087AstraPreat CorporationNHA2022-10-24
00842092127094AstraPreat CorporationNHA2022-10-24
00842092129210PreatPreat CorporationNHA2022-10-24
07630031717757Straumann Computer Aided Restoration Service (C.A.R.E.S.) Ceramic CopingInstitut Straumann AGNHA2022-04-14
07630031701565Straumann Variobase Abutment / IPS e.max CAD restorationsInstitut Straumann AGNHA2019-07-18
07630031701572Straumann Variobase Abutment / IPS e.max CAD restorationsInstitut Straumann AGNHA2019-07-18
07630031701602Straumann Variobase Abutment / IPS e.max CAD restorationsInstitut Straumann AGNHA2019-07-18
07630031701619Straumann Variobase Abutment / IPS e.max CAD restorationsInstitut Straumann AGNHA2019-07-18
07630031701626Straumann Variobase Abutment / IPS e.max CAD restorationsInstitut Straumann AGNHA2019-07-18
07630031701633Straumann Variobase Abutment / IPS e.max CAD restorationsInstitut Straumann AGNHA2019-07-18
07630031701640Straumann Variobase Abutment / IPS e.max CAD restorationsInstitut Straumann AGNHA2019-07-18
EMKA03117ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-12
EMKA10503ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-12
EMKA20503ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-12
EMKA40503ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-12
EMKA02821ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKA03110ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKA03114ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKA03115ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11