FDA.reportPublic FDA data

Bite Rim Sticks

Primary DI
04582275712421
Brand
Bite Rim Sticks
Company
YAMAHACHI DENTAL MFG.,CO.
Model
L, 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

Product Codes#

Code, Name table
CodeName
EGDWax, Dental, Intraoral

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EGDWax, Dental, IntraoralDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04582275712421PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04582275712421045822757124214582275712421

GMDN Terms#

Term, Definition table
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 table
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D080SDGAC17PCSX17C0SHADE GUIDE ACSHADE GUIDE AC,17PCS,17C2025-11-19
D080SDGPX17PCSX17C0SHADE GUIDE CROWN PXSHADE GUIDE CROWN PX,17PCS,17C2025-11-19
04582276126500CROWN PXT61, B22020-06-02
04582276127125CROWN PXT51, B42020-06-11
04582276127149CROWN PXT61, B42020-06-11
04582276127422CROWN PXT41, C12020-06-12
04582276127460CROWN PXT61, C12020-06-12
04582276126401CROWN PXS51, B22020-06-02
04582276126449CROWN PXS71, B22020-06-02
04582276126456CROWN PXS81, B22020-06-02
04582276126463CROWN PXT41, B22020-06-02
04582276126470CROWN PXT41S, B22020-06-02
04582276126487CROWN PXT51, B22020-06-02
04582276126494CROWN PXT51S, B22020-06-02
04582276126517CROWN PXT61S, B22020-06-02
04582276127040CROWN PXS51, B42020-06-11
04582276127088CROWN PXS71, B42020-06-11
04582276127095CROWN PXS81, B42020-06-11
04582276127101CROWN PXT41, B42020-06-11
04582276127118CROWN PXT41S, B42020-06-11

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