FDA.reportPublic FDA data

OCTAGON BL RC Abutment, 0°, Ø 5.0 mm L 6.0 mm, GH 3.0 mm, cementable basic screw

Primary DI
XXXX50221089
Brand
OCTAGON BL RC Abutment, 0°, Ø 5.0 mm L 6.0 mm, GH 3.0 mm, cementable basic screw
Company
Hager & Meisinger Gesellschaft mit beschränkter Haftung
Model
5022108
Catalog number
5022108
Device description
BL RC Abutment, 0°, Ø 5.0 mm L 6.0 mm, GH 3.0 mm, cementable basic screw 22120 incl. for OCTAGON Infinity Dental Implant BL RC
Published
2016-09-08
Public version status
Update
Distribution status
Not 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
XXXX50221089PrimaryHIBCC0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(508)588-3100kathystrange@acesurgical.com

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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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