FDA.reportPublic FDA data

BENCO

Primary DI
00366975057044
Brand
BENCO
Company
BENCO DENTAL SUPPLY CO.
Model
4130-656
Published
2022-08-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
EBHMaterial, Impression Tray, Resin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBHMaterial, Impression Tray, ResinDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00366975057044PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00366975057044003669750570443669750570440366975057044

GMDN Terms#

Term, Definition table
TermDefinition
Dental occlusal splint, custom-madeA rigid or flexible custom-made appliance that overlays the occlusal surfaces of the teeth. It is used to maintain the position of displaced or moveable teeth, to treat teeth clenching and bruxism and their sequelae, and to provide temporary relief from muscle or temporomandibular joint (TMJ) pain (e.g., from TMJ dysfunction). This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
015108087
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00366975012463GIBSON HEALTHCARE5250-9802018-05-31
00366975012470GIBSON HEALTHCARE5250-9992018-05-31
00366975012487GIBSON HEALTHCARE5251-0142018-05-31
00366975012494GIBSON HEALTHCARE5251-0232018-05-31
00366975012500GIBSON HEALTHCARE5251-0322018-06-04
00366975012517GIBSON HEALTHCARE5251-0412018-06-04
00366975012524GIBSON HEALTHCARE5251-0502018-06-04
00366975012531GIBSON HEALTHCARE5251-0692018-06-04
00366975012548GIBSON HEALTHCARE5251-1032018-06-04
00366975012555GIBSON HEALTHCARE5251-1122018-06-04
00366975012562GIBSON HEALTHCARE5251-1212018-06-04
00366975012678GIBSON HEALTHCARE5251-0782018-06-04
00366975012685GIBSON HEALTHCARE5251-0872018-06-04
00366975012692GIBSON HEALTHCARE5251-0962018-06-04
00366975012708GIBSON HEALTHCARE5251-1302018-06-04
00366975072108Sterling6904-7452026-08-27
00366975072115Sterling6904-7542026-08-27
00366975065506Natural Extensions5955-488N35PNK2026-07-30
00366975065513Natural Extensions5955-497N35PNK2026-07-30
00366975065520Natural Extensions5955-504N35PNK2026-07-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06909412313088Light Curing TraySHANDONG HUGE DENTAL MATERIAL CORPORATIONEBH2026-10-26
06909412313095Light Curing TraySHANDONG HUGE DENTAL MATERIAL CORPORATIONEBH2026-10-26
06909412320192Light Curing TraySHANDONG HUGE DENTAL MATERIAL CORPORATIONEBH2026-10-26
06909412320222Light Curing TraySHANDONG HUGE DENTAL MATERIAL CORPORATIONEBH2026-10-26
06909412320413Light Curing TraySHANDONG HUGE DENTAL MATERIAL CORPORATIONEBH2026-10-26
06909412320420Light Curing TraySHANDONG HUGE DENTAL MATERIAL CORPORATIONEBH2026-10-26
06909412320437Light Curing TraySHANDONG HUGE DENTAL MATERIAL CORPORATIONEBH2026-10-26
06970402679033Light Curing TraySHANDONG HUGE DENTAL MATERIAL CORPORATIONEBH2026-10-26
06970402679040Light Curing TraySHANDONG HUGE DENTAL MATERIAL CORPORATIONEBH2026-10-26
06970402679057Light Curing TraySHANDONG HUGE DENTAL MATERIAL CORPORATIONEBH2026-10-26
06970402679064Light Curing TraySHANDONG HUGE DENTAL MATERIAL CORPORATIONEBH2026-10-26
06970402679309Light Curing TraySHANDONG HUGE DENTAL MATERIAL CORPORATIONEBH2026-10-26
06970402679927Light Curing TraySHANDONG HUGE DENTAL MATERIAL CORPORATIONEBH2026-10-26
08800017902395Fish Bone Bite TraysDXM CO., LTDEBH2026-08-25
08800017902401Fish Bone Bite TraysDXM CO., LTDEBH2026-08-25
08800017902418Fish Bone Bite TraysDXM CO., LTDEBH2026-08-25
08800017902425Fish Bone Bite TraysDXM CO., LTDEBH2026-08-25
08800017902432Fish Bone Bite TraysDXM CO., LTDEBH2026-08-25
D14307560147448590Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.EBH2026-07-23
00840456224427JMUJMU DENTAL, INCEBH2026-07-20
00840456224434JMUJMU DENTAL, INCEBH2026-07-20
00840456206942JMUJMU DENTAL, INCEBH2026-07-09
00840456207024JMUJMU DENTAL, INCEBH2026-07-09
00840456207031JMUJMU DENTAL, INCEBH2026-07-09
00840456207048JMUJMU DENTAL, INCEBH2026-07-09
00840456207055JMUJMU DENTAL, INCEBH2026-07-09
00840456207062JMUJMU DENTAL, INCEBH2026-07-09
00840456207079JMUJMU DENTAL, INCEBH2026-07-09
00840456207086JMUJMU DENTAL, INCEBH2026-07-09
00840456207093JMUJMU DENTAL, INCEBH2026-07-09