FDA.report

n/a

Primary DI
E0HM64PHA021
Brand
n/a
Company
Hager & Meisinger Gesellschaft mit beschränkter Haftung
Model
PHA02 070
Catalog number
653204034514070
Device description
Rotary polisher for dental 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
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
EHLPOINT, ABRASIVE

Product Code Classifications

CodeDeviceSpecialtyClass
EHLPoint, AbrasiveDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
E0HM64PHA021PrimaryHIBCC0

GMDN Terms

TermDefinition
Dental abrasive point, single-useA sterile rotary endpiece designed to be attached to a dental power tool handpiece to perform a specific rotating mechanical function during a dental or orthodontic procedure, typically for polishing and smoothing natural or restorative dental materials (e.g., to finish a crown). Also referred to as a polisher, it is available in various forms [e.g., conical] and sizes and is made of synthetic polymer materials (e.g., silicone, rubber). This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1 (303) 268-5400info@meisingerusa.com

Regulatory Flags

DUNS number
318034329
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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