FDA.report

CEREC® Essentials with Celtra® Duo (ZLS) Blocks

Primary DI
D0026071031
Brand
CEREC® Essentials with Celtra® Duo (ZLS) Blocks
Company
DENTSPLY INTERNATIONAL INC.
Model
607103
Catalog number
607103
Device description
CEREC® Essentials Combo Kit with Celtra® Duo (ZLS) Blocks
Published
2022-05-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
EMACEMENT, DENTAL

Product Code Classifications

CodeDeviceSpecialtyClass
EMACement, DentalDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D0026071031PrimaryHIBCC0

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.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Keep away from direct sunlight.
Special Storage Condition, Specify00Protect from moisture.
Storage Environment Temperature10 Degrees Celsius24 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)583-2855MilfordDE-Customer-Service@dentsplysirona.com

Regulatory Flags

DUNS number
083235549
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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