FDA.reportPublic FDA data

n/a

Primary DI
E0HM39MSPB12040081
Brand
n/a
Company
Hager & Meisinger Gesellschaft mit beschränkter Haftung
Model
MSPB1
Catalog number
MSPB1
Device description
Rotary instrument for 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
DZADRILL, DENTAL, INTRAORAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZADrill, Dental, IntraoralDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E0HM39MSPB12040081PrimaryHIBCC0
E0HM39MSPB1204008101Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Steel dental bur, reusableA rotary cutting device made from high-grade carbon steel with the working end typically formed with cutting planes, e.g., spiralled flutes, and which is designed to fit into a dental handpiece that provides the rotation allowing the user to cut hard structures in the mouth, such as teeth or bone. It can also be used to cut hard metals, plastics, porcelains and similar materials intended for use in the fabrication of dental devices. It is available in various shapes (e.g., cylinder, disk, sphere, oval). 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
5
DM exempt
true
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290116154787Dental DrillsNORIS MEDICAL LTDDZA2026-07-09
07290116154794Diamond BurrsNORIS MEDICAL LTDDZA2026-07-09
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06932195393831DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-06-10
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