FDA.report

ORTHOMETRIC ACETATE TRACING PAPER

Primary DI
07898488906975
Brand
ORTHOMETRIC ACETATE TRACING PAPER
Company
ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA
Model
30.20.0300
Catalog number
30.20.0300
Device description
ORTHOMETRIC ACETATE TRACING PAPER 8X10
Published
2022-11-08
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
true

Related Records

Product Codes

CodeName
EFHPaper, Articulation

Product Code Classifications

CodeDeviceSpecialtyClass
EFHPaper, ArticulationDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07898488906975PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07898488906975078984889069757898488906975

GMDN Terms

TermDefinition
Dental articulation paperA strip or sheet of suitable material coated with pigment and used for marking areas of contact between opposite teeth, restorations or appliances. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
898330003
Device count
1
DM exempt
false
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
false

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07908611212061ORTHOMETRIC ELASTIC CHAIN 4.5M - MEDIUM - EMERALD GREEN60.05.61432025-12-22
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07908611212795ORTHOMETRIC ELASTIC CHAIN 1.5M - MEDIUM - TEAL GREEN60.05.60422025-12-22
07908611212856ORTHOMETRIC ELASTIC CHAIN 1.5M - MEDIUM - LIME GREEN60.05.60452025-12-22
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07908611212894ORTHOMETRIC ELASTIC CHAIN 4.5M - SHORT - ACQUA60.05.51412025-12-22

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