FDA.report

Apexit Plus

Primary DI
07615208433265
Brand
Apexit Plus
Company
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
Model
593991AN
Catalog number
593991AN
Device description
Apexit Plus Refill 2x6 g
Published
2022-08-22
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

Product Codes

CodeName
EMACEMENT, DENTAL
KIFRESIN, ROOT CANAL FILLING

Product Code Classifications

CodeDeviceSpecialtyClass
EMACement, DentalDental2
KIFResin, Root Canal FillingDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
DVIV593991AN1PreviousHIBCC0
07615208008654PrimaryGS10
07615208433265Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07615208008654076152080086547615208008654
07615208433265076152084332657615208433265

GMDN Terms

TermDefinition
Hygroscopic dental cementA substance intended for professional use as a dental cement (e.g., luting agent, liner, base, pulp-capping material, root canal sealer) and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction of a hygroscopic inorganic compound(s) [e.g., calcium silicates, calcium aluminates, zinc sulfate, calcium sulfate] with water (hydration). It is intended to be either mixed with water prior to application or react with dentinal fluid in situ. After application, this device cannot be reused.

Sterilization Methods

Method

Regulatory Flags

DUNS number
448015938
Device count
2
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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