FDA.report

Futurabond M

Primary DI
E22113521
Brand
Futurabond M
Company
VOCO GmbH
Model
1352
Catalog number
1352
Device description
Light-curing self-etch-bond reinforced with nano-fillers. Chemical-curing in areas inaccessible with a curing light. Futurabond DC achieves the same adhesive properties as total-etch preparations without seperate etching of the tooth substance. Moisture-tolerant. Durable marginal integrity. Easy and fast application - one-coat, one-cure technique. contains fluorides. No refrigerated storage needed. Ideal for paediatric use.
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
KLEAgent, Tooth Bonding, Resin

Product Code Classifications

CodeDeviceSpecialtyClass
KLEAgent, Tooth Bonding, ResinDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
E22113521PrimaryHIBCC0
E22113520Unit of UseHIBCC0

GMDN Terms

TermDefinition
Dentine bonding agent/setA material(s) primarily intended to be used as a bonding-promoting substance between dentine and a dental composite filling, restorative, or luting material. It includes a resin-based bonding agent and may also include a primer and/or etching solution (as a single formulation or as part of a set); composite resin is not included. It may also be used as an enamel bonding material. After application, this device cannot be reused.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 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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00815967027461RodinPac-Dent, Inc.KLE2026-03-24
00815967027478RodinPac-Dent, Inc.KLE2026-03-24
00815967027485RodinPac-Dent, Inc.KLE2026-03-24
00815967022404PacEtchPac-Dent, Inc.KLE2026-03-23
00815967022411PacEtchPac-Dent, Inc.KLE2026-03-23
00815967022589PacEtchPac-Dent, Inc.KLE2026-03-23
00815967029984RodinPac-Dent, Inc.KLE2026-03-23
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