FDA.reportPublic FDA data

n/a

Primary DI
E0HM39HI3271
Brand
n/a
Company
Hager & Meisinger Gesellschaft mit beschränkter Haftung
Model
HI327
Catalog number
HI327
Device description
Manual instrument for dental/surgical application
Published
2021-09-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
E0HM39HI3271PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental implantation depth/angle gauge, reusableA device designed to be used during the planning and post-osteotomy stages of a dental implantation procedure, prior to surgical implant placement/fixation, to measure/determine various lengths (e.g., drill depth of the osteotomy cavity, mucosal height, distance between implants/teeth for determining the mesiodistal position of the implant) and/or angles [e.g., direction of the perforation in relation to the antagonist arch], typically to help select an appropriate final prosthetic abutment to be installed. It is typically graduated and may be a hand-held instrument or a stand-alone device placed intraorally; some types are intended for use during x-ray imaging. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

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
Sterilization required before use
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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