FDA.report

Horico

Primary DI
EHORC306L1
Brand
Horico
Company
Hopf, Ringleb & Co. GmbH & Cie.
Model
C306L
Device description
Separating strip
Published
2023-06-08
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

Product Codes

CodeName
EHMStrip, Polishing Agent

Product Code Classifications

CodeDeviceSpecialtyClass
EHMStrip, Polishing AgentDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
EHORC306L8PrimaryHIBCC0
EHORC306L1Unit of UseHIBCC0

GMDN Terms

TermDefinition
Dental abrasive strip, single-useA manual dental device in the form of a strip coated with abrasive particles on one or both sides intended to be used for modifying the surface of a tooth or restoration during a dental procedure. It is commonly known as a polishing strip. This is a single-use device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
316612191
Device count
12
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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