FDA.reportPublic FDA data

HORICO

Primary DI
EHORC1623160165
Brand
HORICO
Company
Hopf, Ringleb & Co. GmbH & Cie.
Model
C162 316 016
Device description
Carbide bur
Published
2025-04-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EJLBur, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJLBur, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EHORC1623160165PrimaryHIBCC0
EHORC162316016Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Carbide dental bur, reusableA rotary cutting device made of high-grade steel, the working end of which is made from, or coated with, tungsten carbide, and which is designed to fit into a dental handpiece that provides the rotation allowing the user to cut hard structures in the mouth, e.g., teeth or bone. It can also be used to cut hard metals, plastics, porcelains and similar materials. 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

Regulatory Flags#

DUNS number
316612191
Device count
5
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
EHORAUFG1410185HORICOAuFG1410182025-04-30
EHORAUFG2680145HORICOAuFG2680142025-04-30
EHORFG1410085HORICOFG1410082025-04-30
EHORFG141C0085HORICOFG141C0082025-04-30
EHORFG141C0105HORICOFG141C0102025-04-30
EHORFG141G0185HORICOFG141G0182025-04-30
EHORFG156C0085HORICOFG156C0082025-04-30
EHORFG158M0105HORICOFG158M0102025-04-30
EHORFG165C0105HORICOFG165C0102025-04-30
EHORFG165C0125HORICOFG165C0122025-04-30
EHORFG165C0145HORICOFG165C0142025-04-30
EHORFG165C0165HORICOFG165C0162025-04-30
EHORFG166G0105HORICOFG166G0102025-04-30
EHORFG2180165HORICOFG2180162025-04-30
EHORFG220C0145HORICOFG220C0142025-04-30
EHORFG2680145HORICOFG 268 0142025-04-30
EHORFG277P0215HORICOFG277P0212025-04-30
EHORFG468F0045HORICOFG468F0052025-04-30
EHORFG468F0055HORICOFG468F0052025-04-30
EHORFG539C0105HORICOFG539C0102025-04-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810194409387AiraAIRA, LLCEJL2026-08-25
00810194409431AiraAIRA, LLCEJL2026-08-25
00810194409448AiraAIRA, LLCEJL2026-08-25
00810194409462AiraAIRA, LLCEJL2026-08-25
00810194409486AiraAIRA, LLCEJL2026-08-25
00810194409523AiraAIRA, LLCEJL2026-08-25
00810194409547AiraAIRA, LLCEJL2026-08-25
00810194409554AiraAIRA, LLCEJL2026-08-25
00810194409585AiraAIRA, LLCEJL2026-08-25
00810194409592AiraAIRA, LLCEJL2026-08-25
00810194409608AiraAIRA, LLCEJL2026-08-25
00810194409622AiraAIRA, LLCEJL2026-08-25
00810194409646AiraAIRA, LLCEJL2026-08-25
00810194409776AiraAIRA, LLCEJL2026-08-25
00810194409837AiraAIRA, LLCEJL2026-08-25
00810194409912AiraAIRA, LLCEJL2026-08-25
00810194409943AiraAIRA, LLCEJL2026-08-25
00810194409950AiraAIRA, LLCEJL2026-08-25
00810194409981AiraAIRA, LLCEJL2026-08-25
00810226100022AiraAIRA, LLCEJL2026-08-25
00810226100060AiraAIRA, LLCEJL2026-08-25
00810226100138AiraAIRA, LLCEJL2026-08-25
00810226100213AiraAIRA, LLCEJL2026-08-25
00810226100268AiraAIRA, LLCEJL2026-08-25
00810226100275AiraAIRA, LLCEJL2026-08-25
00810226100572AiraAIRA, LLCEJL2026-08-25
00810226100985AiraAIRA, LLCEJL2026-08-25
00810226101043AiraAIRA, LLCEJL2026-08-25
00810226101050AiraAIRA, LLCEJL2026-08-25
00810226101081AiraAIRA, LLCEJL2026-08-25