FDA.report

FOTOPLUS

Primary DI
07897990342011
Brand
FOTOPLUS
Company
TDV DENTAL LTDA
Model
0005010000
Catalog number
0005010000
Device description
Fotoplus - 2 Instruments (PT/ES/EN/FR)
Published
2025-02-28
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

Product Codes

CodeName
EIYInstrument, Filling, Plastic, Dental

Product Code Classifications

CodeDeviceSpecialtyClass
EIYInstrument, Filling, Plastic, DentalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07897990342011PrimaryGS10

GMDN Terms

TermDefinition
Dental spatula, reusableA hand-held manual dental device used to manipulate filling materials in the plastic state. It is typically made of stainless steel with a small, flat, blunt blade (no sharp edges) at one end, or it may be double-ended. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
900580358
Device count
1
DM exempt
true
Premarket exempt
true
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
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
07897990399091UNIMATRIX S000302030100030203012026-02-18
07897990399213UNIMATRIX S000302030000030203002026-02-18
07897990399220UNIMATRIX S000302030200030203022026-02-18
07897990301919METALLIC MATRIX STRIP000306000700030600072025-03-04
07897990301940METALLIC MATRIX STRIP000306001000030600102025-03-04
07897990302244ANATOMIC WEDGES000402002200040200222025-03-04
07897990302251ANATOMIC WEDGES000402002300040200232025-03-04
07897990302268ANATOMIC WEDGES000402002400040200242025-03-04
07897990302343MICROCUT MANUAL000500000700050000072025-03-04
07897990302428TRANSPARENT CROWNS000800000500080000052025-03-04
07897990302435TRANSPARENT CROWNS000800000600080000062025-03-04
07897990302442TRANSPARENT CROWNS000800000700080000072025-03-04
07897990302466TRANSPARENT CROWNS000800000900080000092025-03-04
07897990306297METALLIC MATRIX STRIP000306001800030600182025-03-04
07897990306303METALLIC MATRIX STRIP000306001900030600192025-03-04
07897990307126TRANSPARENT CROWNS000800050000080005002025-03-04
07897990307133TRANSPARENT CROWNS000800050100080005012025-03-04
07897990307140TRANSPARENT CROWNS000800050200080005022025-03-04
07897990307157TRANSPARENT CROWNS000800050300080005032025-03-04
07897990307164TRANSPARENT CROWNS000800050400080005042025-03-04

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