FDA.reportPublic FDA data

n/a

Primary DI
E0HM64PCL10101
Brand
n/a
Company
Hager & Meisinger Gesellschaft mit beschränkter Haftung
Model
PCL10 030
Catalog number
633204243537030
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
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
EHLPOINT, ABRASIVE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EHLPoint, AbrasiveDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E0HM64PCL101PrimaryHIBCC0
E0HM64PCL10101Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental abrasive point, reusableA rotary endpiece designed to be attached to a dental power tool handpiece to produce an abrasive rotation typically for polishing and smoothing natural or restorative dental materials (e.g., crown) during a dental procedure. Also referred to as a polisher, it is available in various forms (e.g., conical), sizes, and materials [e.g., silicone, rubber, metal, diamond, silicon carbide, aluminium oxide]. 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
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
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
E0HM266736436BE00101n/a6736-4366736-4362026-02-04
E0HM266736445BE00101n/a6736-4456736-4452026-02-04
E0HM266736454BE00101n/a6736-4546736-4542026-02-04
E0HM266736463BE00101n/a6736-4636736-4632026-02-04
E0HM2900560317005101n/aHM560 0055003171940060052026-02-04
E0HM39MU1860140021n/aMU186 002MU186 0022026-02-04
E0HM740IVK011n/aIVK01IVK012026-02-04
E0HM740IVK021n/aIVK01IVK012026-02-04
E0HM740IVK031n/aIVK01IVK012026-02-04
E0HM79BIE001Bone ManagementBIE00BIE002026-02-04
E0HMSAGE011n/aSAGE01SAGE012026-02-04
E0HM266735268BE00101n/a6735-2686735-2682025-07-11
E0HM266736230BE00101n/a6736-2306736-2302025-07-11
E0HM266736285BE00101n/a6736-2856736-2852025-07-11
E0HM266736338BE00101n/a6736-3386736-3382025-07-11
E0HM266736383BE00101n/a6736-3836736-3832025-07-11
E0HM39310540000001Bone Management31054310542025-07-11
E0HM39MSTDW1Bone ManagementMSTDWMSTDW2025-07-11
E0HM740SSA011n/aSSA01SSA012025-07-11
E0HM79WPP211n/aWPP21WPP212025-07-11

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08404535024609Brasseler USAPeter Brasseler Holdings, LLCEHL2026-03-17
08404535024630Brasseler USAPeter Brasseler Holdings, LLCEHL2026-03-17
08404535024661Brasseler USAPeter Brasseler Holdings, LLCEHL2026-03-17
00840479201481RENEW SYSTEM POINTSRELIANCE ORTHODONTIC PRODUCTS INCEHL2026-03-13
07908738730141DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHL2026-03-13
07908738730158DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHL2026-03-13
07908738730165DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHL2026-03-13
07908738730172DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHL2026-03-13
07908738730189DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHL2026-03-13
07908738730196DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHL2026-03-13
07908738730202DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHL2026-03-13
07908738730219DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHL2026-03-13
07908738730226DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHL2026-03-13
07908738730233DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHL2026-03-13
07908738730240DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHL2026-03-13
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07908738730264DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHL2026-03-13
07908738730271DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHL2026-03-13
07908738730288DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHL2026-03-13
07908738730295DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHL2026-03-13
07908738730479DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHL2026-03-13
07908738730486DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHL2026-03-13
07908738730493DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHL2026-03-13
07908738730523DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHL2026-03-13
07908738730530DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHL2026-03-13
07908738730547DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHL2026-03-13
07908738737775DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHL2026-03-13
00840479202495RENEW SYSTEM POINTSRELIANCE ORTHODONTIC PRODUCTS INCEHL2026-03-11
00840479202501RENEW SYSTEM POINTSRELIANCE ORTHODONTIC PRODUCTS INCEHL2026-03-11