FDA.report

CERAMISTE

Primary DI
E23505950
Brand
CERAMISTE
Company
SHOFU DENTAL CORPORATION
Model
0595
Catalog number
0595
Device description
UM CERAMISTE SOFT WHEEL PA
Published
2021-02-03
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

Contact Domains

Product Codes

CodeName
EHJDISK, ABRASIVE

Product Code Classifications

CodeDeviceSpecialtyClass
EHJDisk, AbrasiveDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
E23505950PrimaryHIBCC0

GMDN Terms

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
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(800)827-5262customer-service@shofu.com

Regulatory Flags

DUNS number
054618202
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
true

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