FDA.reportPublic FDA data

KISSES Plus Implant System

Primary DI
08800024953069
Brand
KISSES Plus Implant System
Company
Achimhai Medical Corporation
Model
KCC-N
Catalog number
KCC-N
Device description
CCM Abutment / Non-Hex / Diameter: 4.5mm / Length: 17.05mm
Published
2021-08-24
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
NHAAbutment, Implant, Dental, Endosseous

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200193000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200193000Kisses Plus Implant SystemAchimhai Medical Corporation2021-08-06NHA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800024953069PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800024953069088000249530698800024953069

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant suprastructure, permanent, preformedA prefabricated device intended to provide a permanent intermediate fixture level between a dental implant and the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It includes one or more structural component(s) [e.g., abutment, ball, bar, bar overlay, coping, ring], and may be made of various materials [e.g., titanium (Ti), plastic, gold alloy]. It includes devices glued to prostheses and/or devices that can be replaced during cleaning cycles. An abutment screw(s) may be included, however the suprastructure does not represent the screw(s) in isolation. It may also be referred to as an abutment assembly or mesostructure.

Storage And Handling#

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

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
694197900
Device count
1
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
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
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EMKA03110ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKA03114ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKA03115ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKA10502ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKA20502ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKA40502ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKA80ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
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EMKA8515TET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKAB80ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKAB80TET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKABS80PSET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKABS80TET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKABS81PSET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKABS82PSET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKABS83PSET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKAC80ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKAC80TET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKAC81ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
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EMKAC82TET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11