FDA.report

Meron

Primary DI
E222112421
Brand
Meron
Company
VOCO GmbH
Model
1242
Catalog number
1242
Device description
Dual-curing universal composite-based luting system. For all materials (metal, composite inlays and ceramic, also zirconium dioxide). Bubble-free perfect mixing. Direct application. Excellent adhesion to dentine, enamel and to metals. Special one-step Ceramic bond for optimal adhesion to porcelain. Radiopaque. Available in three shadese. Try-In pastes simplify shade selection before cementation. All-in-one set.
Published
2016-08-31
Public version status
Update
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
EMACement, Dental

Product Code Classifications

CodeDeviceSpecialtyClass
EMACement, DentalDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
E222112421PrimaryHIBCC0
E222112420Unit of UseHIBCC0

GMDN Terms

TermDefinition
Glass ionomer dental cementA non-sterile substance intended for professional use as a dental cement (e.g., luting agent, liner, base, pulp-capping material) and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction between an aluminosilicate glass powder and an aqueous solution of a polyalkenoic acid. It typically includes some additional fillers, and may include setting substances that are in the minority (e.g., resin, metal). After application, this device cannot be reused.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius23 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
999-999-9999xxx@xx.xx

Regulatory Flags

DUNS number
316699578
Device count
50
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
false
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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