FDA.report

Bite Rim Sticks

Primary DI
04582594040595
Brand
Bite Rim Sticks
Company
YAMAHACHI DENTAL MFG.,CO.
Model
sample SL, LIGHT PINK
Published
2021-04-29
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
EGDWax, Dental, Intraoral

Product Code Classifications

CodeDeviceSpecialtyClass
EGDWax, Dental, IntraoralDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04582594040595PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04582594040595045825940405954582594040595

GMDN Terms

TermDefinition
Bite registration rim waxA dental material (modelling wax) with or without reinforcing foils (metal, polymer) for registration of jaw relation (making bite rims). This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
693430001
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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