FDA.report

MAZIC Claro CAD

Primary DI
08800123829005
Brand
MAZIC Claro CAD
Company
VERICOM CO., LTD.
Model
MCC32-LBL4
Device description
Glass Ceramic for CAD System; B32, LT BL4 Mandrel type*3ea
Published
2025-07-01
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

Contact Domains

Product Codes

CodeName
EIHPowder, Porcelain

Product Code Classifications

CodeDeviceSpecialtyClass
EIHPowder, PorcelainDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08800123822785PrimaryGS10
08800123829005Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08800123822785088001238227858800123822785
08800123829005088001238290058800123829005

GMDN Terms

TermDefinition
Dental appliance fabrication material, ceramicA dental material made of ceramic materials (e.g., zirconium oxide) intended to be used to manufacture a final dental prosthesis (e.g., a dental implant, removable dentures, crown, bridge) for patient use. It is used to create implantable and removable restorations using manual or computer-aided design/computer-aided manufacturing (CAD/CAM) technology. After application, this material cannot be reused for fabrication.

Sterilization Methods

Method

Contacts

PhoneEmail
+82314412881vericom@vericom.co.kr

Regulatory Flags

DUNS number
689698269
Device count
3
DM exempt
false
Premarket exempt
false
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
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
08800123819730Well-Root PTWT225-SE002025-11-27
08800123819747Well-Root PTWT202-KE002025-11-27
08800123819754Well-Root PTWT201-EE002025-11-27
08809254459402Well-Root PTWT225-S0002025-11-27
08809254459419Well-Root PTWT202-K0002025-11-27
08800123821757MAZIC Claro CADMCC14-HTA52025-07-01
08800123821764MAZIC Claro CADMCC14-HTA42025-07-01
08800123821771MAZIC Claro CADMCC14-HTB12025-07-01
08800123821788MAZIC Claro CADMCC14-HTB22025-07-01
08800123821795MAZIC Claro CADMCC14-HTB32025-07-01
08800123821801MAZIC Claro CADMCC14-HTB42025-07-01
08800123821818MAZIC Claro CADMCC14-HTC12025-07-01
08800123821825MAZIC Claro CADMCC14-HTC22025-07-01
08800123821832MAZIC Claro CADMCC14-HTC32025-07-01
08800123821849MAZIC Claro CADMCC14-HTC42025-07-01
08800123821856MAZIC Claro CADMCC14-HTD22025-07-01
08800123821863MAZIC Claro CADMCC14-HTD32025-07-01
08800123821870MAZIC Claro CADMCC14-HTD42025-07-01
08800123821887MAZIC Claro CADMCC14-0BL12025-07-01
08800123821894MAZIC Claro CADMCC14-0BL22025-07-01

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