FDA.reportPublic FDA data

Oneday Mini Implant System

Primary DI
08800075208682
Brand
Oneday Mini Implant System
Company
Oneday Biotech Co.,Ltd.
Model
MTAN4074H
Published
2026-06-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
false
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
K222946000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222946000Oneday Mini Implant SystemOneday Biotech Co., Ltd.2023-08-23DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800075208682PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800075208682088000752086828800075208682

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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
694607898
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800075200051I DoS3811C2026-06-04
08800075200068I DoS3813C2026-06-04
08800075200075I DoS3815C2026-06-04
08800075200082I DoS4007C2026-06-04
08800075200099I DoS4008C2026-06-04
08800075200105I DoS4010C2026-06-04
08800075200112I DoS4011C2026-06-04
08800075200129I DoS4013C2026-06-04
08800075200136I DoS4015C2026-06-04
08800075200143I DoS4507C2026-06-04
08800075200150I DoS4508C2026-06-04
08800075200167I DoS4510C2026-06-04
08800075200174I DoS4511C2026-06-04
08800075200181I DoS4513C2026-06-04
08800075200198I DoS4515C2026-06-04
08800075200204I DoS5007C2026-06-04
08800075200211I DoS5008C2026-06-04
08800075200228I DoS5010C2026-06-04
08800075200235I DoS5011C2026-06-04
08800075200242I DoS5013C2026-06-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800075201041I DoOneday Biotech Co.,Ltd.NHA2026-06-04
08800075201058I DoOneday Biotech Co.,Ltd.NHA2026-06-04
08800075201065I DoOneday Biotech Co.,Ltd.NHA2026-06-04
08800075201072I DoOneday Biotech Co.,Ltd.NHA2026-06-04
08800075202048Oneday Mini Implant SystemOneday Biotech Co.,Ltd.NHA2026-06-04
08800075208613Oneday Mini Implant SystemOneday Biotech Co.,Ltd.NHA2026-06-04
08800075208620Oneday Mini Implant SystemOneday Biotech Co.,Ltd.NHA2026-06-04
08800075208637Oneday Mini Implant SystemOneday Biotech Co.,Ltd.NHA2026-06-04
08800075208644Oneday Mini Implant SystemOneday Biotech Co.,Ltd.NHA2026-06-04
08800075208651Oneday Mini Implant SystemOneday Biotech Co.,Ltd.NHA2026-06-04
08800075208668Oneday Mini Implant SystemOneday Biotech Co.,Ltd.NHA2026-06-04
08800075208675Oneday Mini Implant SystemOneday Biotech Co.,Ltd.NHA2026-06-04
08800075208699Oneday Mini Implant SystemOneday Biotech Co.,Ltd.NHA2026-06-04
08800075208705Oneday Mini Implant SystemOneday Biotech Co.,Ltd.NHA2026-06-04
08800075208712Oneday Mini Implant SystemOneday Biotech Co.,Ltd.NHA2026-06-04
08800075208729Oneday Mini Implant SystemOneday Biotech Co.,Ltd.NHA2026-06-04
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