FDA.reportPublic FDA data

OKTAGON BL NC Basic screw, L 7.85 mm

Primary DI
E0HM220431
Brand
OKTAGON BL NC Basic screw, L 7.85 mm
Company
Hager & Meisinger Gesellschaft mit beschränkter Haftung
Model
22043
Catalog number
22043
Device description
BL NC Basic screw, L 7.85 mm for OKTAGON Dental Implant BL NC
Published
2021-06-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

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
K143539000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K143539000Dental Implant OKTAGON Bone LevelHager& Meisinger GmbH2015-08-31DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E0HM220431PrimaryHIBCC0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+492173398000info@dental-ratio.de

Regulatory Flags#

DUNS number
318034329
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
E0HM36KHKS1Bone ManagementKHKS1KHKS12026-10-23
E0HM51008203140041n/a51008203140048063144655040042026-10-23
E0HM510820C3140021n/a510820C3140028063144655040022026-10-23
E0HM510820C3140031n/a510820C3140038063144655040032026-10-23
E0HM510820G3140051n/a510820G3140058063144655040052026-10-23
E0HM72C1170FG1n/aC1170FGC1170FG2026-10-23
E0HM72C169FG1n/aC169FGC169FG2026-10-23
E0HM74UFLV22n/aUFLV22UFLV222026-10-09
E0HM210023R2040181n/aHM23R 018500 204 194 006 0182026-08-17
E0HM25251GM1040601n/aHM251GM 060500 104 274 191 0602026-08-17
E0HM25251SX1040601n/aHM251SX 060500 104 274 224 0602026-08-17
E0HM29001912040051n/aHM191 005HM191 0052026-08-17
E0HM29001912040141n/aHM191 014HM191 0142026-08-17
E0HM72C703LHP1n/aC703LHPC703LHP2025-01-15
E0HM74MOD021n/aMOD02MOD022026-03-18
E0HM21000212040141n/aHM21 0145002041070060142026-07-24
E0HM22000013160121n/aHM1 0125003160010010122026-07-24
E0HM22000013160161n/aHM1 0165003160010010162026-07-24
E0HM22000013160211n/aHM1 0215003160010010212026-07-24
E0HM25079FX1040401n/aHM79FX 0405001041941400402026-07-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800077020022ZEROS Dental Implant SystemZEROS Co., Ltd.NHA2026-10-30
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08800077020664ZEROS Dental Implant SystemZEROS Co., Ltd.NHA2026-10-30
08800077020671ZEROS Dental Implant SystemZEROS Co., Ltd.NHA2026-10-30
08800077020688ZEROS Dental Implant SystemZEROS Co., Ltd.NHA2026-10-30
08800077020695ZEROS Dental Implant SystemZEROS Co., Ltd.NHA2026-10-30
08800077020701ZEROS Dental Implant SystemZEROS Co., Ltd.NHA2026-10-30
08800077020718ZEROS Dental Implant SystemZEROS Co., Ltd.NHA2026-10-30
08800077020725ZEROS Dental Implant SystemZEROS Co., Ltd.NHA2026-10-30
08800077020732ZEROS Dental Implant SystemZEROS Co., Ltd.NHA2026-10-30
08800077020749ZEROS Dental Implant SystemZEROS Co., Ltd.NHA2026-10-30
08800077020756ZEROS Dental Implant SystemZEROS Co., Ltd.NHA2026-10-30
08800077020763ZEROS Dental Implant SystemZEROS Co., Ltd.NHA2026-10-30
08800077020770ZEROS Dental Implant SystemZEROS Co., Ltd.NHA2026-10-30
08800077020787ZEROS Dental Implant SystemZEROS Co., Ltd.NHA2026-10-30
08800077020794ZEROS Dental Implant SystemZEROS Co., Ltd.NHA2026-10-30
08800077020800ZEROS Dental Implant SystemZEROS Co., Ltd.NHA2026-10-30
08800077020817ZEROS Dental Implant SystemZEROS Co., Ltd.NHA2026-10-30
08800077020824ZEROS Dental Implant SystemZEROS Co., Ltd.NHA2026-10-30
08800077020831ZEROS Dental Implant SystemZEROS Co., Ltd.NHA2026-10-30
08800077020848ZEROS Dental Implant SystemZEROS Co., Ltd.NHA2026-10-30
08800077020855ZEROS Dental Implant SystemZEROS Co., Ltd.NHA2026-10-30
08800077020862ZEROS Dental Implant SystemZEROS Co., Ltd.NHA2026-10-30
08800077020879ZEROS Dental Implant SystemZEROS Co., Ltd.NHA2026-10-30
08800077020886ZEROS Dental Implant SystemZEROS Co., Ltd.NHA2026-10-30
08800077020893ZEROS Dental Implant SystemZEROS Co., Ltd.NHA2026-10-30
08800077020909ZEROS Dental Implant SystemZEROS Co., Ltd.NHA2026-10-30
08800077020916ZEROS Dental Implant SystemZEROS Co., Ltd.NHA2026-10-30