FDA.report

HORICO

Primary DI
EHORFG2390141
Brand
HORICO
Company
Hopf, Ringleb & Co. GmbH & Cie.
Model
FG 239 014
Device description
Rotary diamond instrument
Published
2023-07-14
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

Related Records

Product Codes

CodeName
DZPInstrument, Diamond, Dental

Product Code Classifications

CodeDeviceSpecialtyClass
DZPInstrument, Diamond, DentalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
EHORFG2390145PrimaryHIBCC0
EHORFG2390141Unit of UseHIBCC0

GMDN Terms

TermDefinition
Diamond dental bur, reusableA rotary cutting device made of high-grade steel with the working end coated with particles of diamond, 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
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
316612191
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
true
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 DIBrandModelCatalogPublished
EHORAUFG1410181HORICOAuFG141 0182025-04-30
EHORAUFG141018HORICOAuFG1410182025-04-30
EHORAUFG2680141HORICOAuFG2680142025-04-30
EHORAUFG268014HORICOAuFG2680142025-04-30
EHORC1623160161HORICOC162 316 0162025-04-30
EHORC162316016HORICOC162 316 0162025-04-30
EHORFG1410081HORICOFG1410082025-04-30
EHORFG141008HORICOFG1410082025-04-30
EHORFG141C0081HORICOFG141C0082025-04-30
EHORFG141C008HORICOFG141C0082025-04-30
EHORFG141C0101HORICOFG141C0102025-04-30
EHORFG141C010HORICOFG141C0102025-04-30
EHORFG141G0181HORICOFG141G0182025-04-30
EHORFG141G018HORICOFG141G0182025-04-30
EHORFG156C0081HORICOFG156C0082025-04-30
EHORFG156C008HORICOFG156C0082025-04-30
EHORFG158M0101HORICOFG158M0102025-04-30
EHORFG158M010HORICOFG158M0102025-04-30
EHORFG165C0101HORICOFG165C0102025-04-30
EHORFG165C010HORICOFG165C0102025-04-30

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