FDA.report

ZMD-1000B Model

Primary DI
08800053015035
Brand
ZMD-1000B Model
Company
DENTIS CO. ,LTD
Model
ZMD-1000B Model
Device description
Dental Model Resin / ZMD-1000B Model
Published
2021-06-03
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
true

Related Records

Product Codes

CodeName
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications

CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08800053015035PrimaryGS10

GMDN Terms

TermDefinition
Tactile orientation materialA device used by a person with a disability who has an impaired sense of orientation, typically a blind person, to self-orient in their surroundings, e.g., at home, work, and in the normal daily life of society. It consists of special tactile-material, including structured surfaces, to provide the user with information pertaining to their surroundings and function as signs to provide the user with known orientation points.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
694721181
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
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

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