FDA.reportPublic FDA data

OKTAGON®

Primary DI
E0HM220961
Brand
OKTAGON®
Company
Hager & Meisinger Gesellschaft mit beschränkter Haftung
Model
22096
Catalog number
22096
Device description
Device for prosthetic application (impression, laboratory)
Published
2021-09-15
Public version status
New
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
NDPAccessories, implant, dental, endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E0HM220961PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant abutment impression capA small device intended to be placed intraorally on the abutment head of a dental implant during a dental impression to facilitate removal of the impression material once it has hardened, and to reproduce the intraoral position and orientation of the abutment/implant in a dental laboratory working model, for the fabrication of a final dental prosthesis (e.g., denture). This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1 (303) 268-5400info@meisingerusa.com

Regulatory Flags#

DUNS number
318034329
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
EDRS220011OKTAGON Dental Implant BL RC22001220012015-10-01
EDRS220021OKTAGON Dental Implant BL RC22002220022015-10-01
EDRS220031OKTAGON Dental Implant BL RC22003220032015-10-01
EDRS220041OKTAGON Dental Implant BL RC22004220042015-10-01
EDRS220051OKTAGON Dental Implant BL RC22005220052015-10-01
EDRS220061OKTAGON Dental Implant BL RC22006220062015-10-01
EDRS220071OKTAGON Dental Implant BL RC22007220072015-10-01
EDRS220081OKTAGON Dental Implant BL RC22008220082015-10-01
EDRS220091OKTAGON Dental Implant BL NC22009220092015-10-01
EDRS220101OKTAGON Dental Implant BL NC22010220102015-10-01
EDRS220111OKTAGON Dental Implant BL NC22011220112015-10-01
EDRS220121OKTAGON Dental Implant BL NC22012220122015-10-01
EDRS220131OKTAGON BL NC Cover screw GH 0.0 mm22013220132017-01-27
EDRS220141OKTAGON BL NC Cover screw GH 0.5 mm22014220142017-01-27
EDRS220171OKTAGON BL NC Healing abutment, conical Ø3.6 mm GH 2.0 mm22017220172017-01-27
EDRS220181OKTAGON BL NC Healing abutment, conical Ø3.6 mm GH 3.5 mm22018220182017-01-27
EDRS220191OKTAGON BL NC Healing abutment, conical Ø3.6 mm GH 5.0 mm22019220192017-01-27
EDRS220201OKTAGON BL NC Healing abutment, conical Ø4.8 mm GH 2.0 mm22020220202017-01-27
EDRS220211OKTAGON BL NC Healing abutment, conical Ø4.8 mm GH 3.5 mm22021220212017-01-27
EDRS220221OKTAGON BL NC Healing abutment, conical Ø4.8 mm GH 5.0 mm22022220222017-01-27

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Primary DI, Brand, Company table
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