FDA.reportPublic FDA data

ZEROS Dental Implant System

Primary DI
08800077000215
Brand
ZEROS Dental Implant System
Company
ZEROS Co., Ltd.
Model
FM2R46070
Published
2026-10-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DZEImplant, Endosseous, Root-Form

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZEImplant, Endosseous, Root-FormDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K260463000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K260463000ZEROS Dental Implant SystemZeros Co., Ltd.2026-08-19DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800077000215PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800077000215088000770002158800077000215

Contacts#

Phone, Email table
PhoneEmail
+82559050094changkim100@naver.com

Regulatory Flags#

DUNS number
694099399
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
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
08800077000031ZEROS Dental Implant SystemFM2R380852026-10-30
08800077000055ZEROS Dental Implant SystemFM2R381002026-10-30
08800077000079ZEROS Dental Implant SystemFM2R381152026-10-30
08800077000093ZEROS Dental Implant SystemFM2R381302026-10-30
08800077000116ZEROS Dental Implant SystemFM2R420702026-10-30
08800077000130ZEROS Dental Implant SystemFM2R420852026-10-30
08800077000154ZEROS Dental Implant SystemFM2R421002026-10-30
08800077000178ZEROS Dental Implant SystemFM2R421152026-10-30
08800077000192ZEROS Dental Implant SystemFM2R421302026-10-30
08800077000239ZEROS Dental Implant SystemFM2R460852026-10-30
08800077000253ZEROS Dental Implant SystemFM2R461002026-10-30
08800077000277ZEROS Dental Implant SystemFM2R461152026-10-30
08800077000291ZEROS Dental Implant SystemFM2R461302026-10-30
08800077000321ZEROS Dental Implant SystemFM2R510702026-10-30
08800077000345ZEROS Dental Implant SystemFM2R510852026-10-30
08800077000369ZEROS Dental Implant SystemFM2R511002026-10-30
08800077000383ZEROS Dental Implant SystemFM2R511152026-10-30
08800077000406ZEROS Dental Implant SystemFM2R511302026-10-30
08800077000437ZEROS Dental Implant SystemFM2R550702026-10-30
08800077000451ZEROS Dental Implant SystemFM2R550852026-10-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800077000031ZEROS Dental Implant SystemZEROS Co., Ltd.DZE2026-10-30
08800077000055ZEROS Dental Implant SystemZEROS Co., Ltd.DZE2026-10-30
08800077000079ZEROS Dental Implant SystemZEROS Co., Ltd.DZE2026-10-30
08800077000093ZEROS Dental Implant SystemZEROS Co., Ltd.DZE2026-10-30
08800077000116ZEROS Dental Implant SystemZEROS Co., Ltd.DZE2026-10-30
08800077000130ZEROS Dental Implant SystemZEROS Co., Ltd.DZE2026-10-30
08800077000154ZEROS Dental Implant SystemZEROS Co., Ltd.DZE2026-10-30
08800077000178ZEROS Dental Implant SystemZEROS Co., Ltd.DZE2026-10-30
08800077000192ZEROS Dental Implant SystemZEROS Co., Ltd.DZE2026-10-30
08800077000239ZEROS Dental Implant SystemZEROS Co., Ltd.DZE2026-10-30
08800077000253ZEROS Dental Implant SystemZEROS Co., Ltd.DZE2026-10-30
08800077000277ZEROS Dental Implant SystemZEROS Co., Ltd.DZE2026-10-30
08800077000291ZEROS Dental Implant SystemZEROS Co., Ltd.DZE2026-10-30
08800077000321ZEROS Dental Implant SystemZEROS Co., Ltd.DZE2026-10-30
08800077000345ZEROS Dental Implant SystemZEROS Co., Ltd.DZE2026-10-30
08800077000369ZEROS Dental Implant SystemZEROS Co., Ltd.DZE2026-10-30
08800077000383ZEROS Dental Implant SystemZEROS Co., Ltd.DZE2026-10-30
08800077000406ZEROS Dental Implant SystemZEROS Co., Ltd.DZE2026-10-30
08800077000437ZEROS Dental Implant SystemZEROS Co., Ltd.DZE2026-10-30
08800077000451ZEROS Dental Implant SystemZEROS Co., Ltd.DZE2026-10-30
08800077000475ZEROS Dental Implant SystemZEROS Co., Ltd.DZE2026-10-30
08800077000499ZEROS Dental Implant SystemZEROS Co., Ltd.DZE2026-10-30
08800077000512ZEROS Dental Implant SystemZEROS Co., Ltd.DZE2026-10-30
08800077000543ZEROS Dental Implant SystemZEROS Co., Ltd.DZE2026-10-30
08800077000567ZEROS Dental Implant SystemZEROS Co., Ltd.DZE2026-10-30
08800077000581ZEROS Dental Implant SystemZEROS Co., Ltd.DZE2026-10-30
08800077000604ZEROS Dental Implant SystemZEROS Co., Ltd.DZE2026-10-30
08800077000628ZEROS Dental Implant SystemZEROS Co., Ltd.DZE2026-10-30
08800077001038ZEROS Dental Implant SystemZEROS Co., Ltd.DZE2026-10-30
08800077001052ZEROS Dental Implant SystemZEROS Co., Ltd.DZE2026-10-30