FDA.reportPublic FDA data

Maxima Radiopaque Kit

Primary DI
10304040000868
Brand
Maxima Radiopaque Kit
Company
HENRY SCHEIN, INC.
Model
2283013
Catalog number
2283013
Device description
Maxima Radiopaque Kit
Published
2016-09-24
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

Product Codes#

Code, Name table
CodeName
ELMDenture, plastic, teeth

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ELMDenture, Plastic, TeethDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K102874000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K102874000NEW STETIC ACRYLICSNew Stetic2011-03-28EBI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10304040000868PackageGS113In Commercial Distribution
00304040000861PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1030404000086810304040000868
00304040000861003040400008613040400008610304040000861

GMDN Terms#

Term, Definition table
TermDefinition
Resin artificial teethPrefabricated teeth made of polymer-based material for mounting on dentures. Teeth are normally delivered as sets of front teeth, upper or lower jaw, or sets of premolars and molars, upper or lower jaw, in various sizes, shapes and colours.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Storage this product in a cool and dry area
Storage Environment Temperature2 Degrees Celsius23 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
012430880
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
true
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
10304040196974Henry Schein570586457058642026-05-14
10304040196981Henry Schein570586557058652026-05-14
10304040196998Henry Schein570586657058662026-05-14
10304040197001Henry Schein570586757058672026-05-14
10304040197018Henry Schein570586857058682026-05-14
10304040059446Henry Schein900445490044542019-02-13
10304040196790Henry Schein570584657058462026-04-21
10304040196806Henry Schein570584957058492026-04-21
10304040196660Henry Schein570583757058372026-04-17
10304040196677Henry Schein570583857058382026-04-17
10304040196684Henry Schein570583957058392026-04-17
10304040196691Henry Schein570584057058402026-04-17
10304040196707Henry Schein570584157058412026-04-17
10304040196714Henry Schein570584257058422026-04-17
10304040196653Henry Schein570583157058312026-04-10
00304040000236Henry Schein100-7773100-77732015-09-25
10304040119034Henry Schein570163357016332020-02-05
10304040119058Henry Schein570163457016342020-02-05
10304040119065Henry Schein570163657016362020-02-05
10304040119089Henry Schein570163857016382020-02-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
EGEB290040TRIBOS 501 C Composite teeth SLA-UJ-3,5Gebdi Dental-Products GmbHELM2026-06-03
EPOLCL01A2CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL01A3CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL01A4CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL01A9CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL01B1CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL01B2CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL01B3CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL01B4CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL01C1CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL01C2CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL01C3CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL01C4CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL01D2CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL01D3CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL01D4CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL01L3CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL02A1CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL02A2CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL02A3CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL02A4CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL02A9CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL02B1CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL02B2CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL02B3CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL02B4CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL02C1CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL02C2CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL02C3CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL02C4CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10