FDA.reportPublic FDA data

OCTAGON Infinity BL RC Burn-out plastic coping for bridge/bar, Ø 5.0 mm

Primary DI
XXXX50221169
Brand
OCTAGON Infinity BL RC Burn-out plastic coping for bridge/bar, Ø 5.0 mm
Company
Hager & Meisinger Gesellschaft mit beschränkter Haftung
Model
5022116
Catalog number
5022116
Device description
BL RC Burn-out plastic coping for bridge/bar, Ø 5.0 mm 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
XXXX50221169PrimaryHIBCC0

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
088000968582008plant Implant System8dent Inc.NHA2026-11-04
088000968584398plant Implant System8dent Inc.NHA2026-11-04
088000968586998plant Implant System8dent Inc.NHA2026-11-04
088000968602108plant Implant System8dent Inc.NHA2026-11-04
088000968602278plant Implant System8dent Inc.NHA2026-11-04
088000968612318plant Implant System8dent Inc.NHA2026-11-04
088000968612488plant Implant System8dent Inc.NHA2026-11-04
088000968622908plant Implant System8dent Inc.NHA2026-11-04
088000968686058plant Implant System8dent Inc.NHA2026-11-04
088000968788578plant Implant System8dent Inc.NHA2026-11-04
00840481137181LOCATOR Angled AbutmentZest Anchors, LLCNHA2026-11-03
08800077020022ZEROS Dental Implant SystemZEROS Co., Ltd.NHA2026-10-30
08800077020053ZEROS Dental Implant SystemZEROS Co., Ltd.NHA2026-10-30
08800077020640ZEROS Dental Implant SystemZEROS Co., Ltd.NHA2026-10-30
08800077020657ZEROS Dental Implant SystemZEROS Co., Ltd.NHA2026-10-30
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