FDA.reportPublic FDA data

BENCO

Primary DI
00366975052773
Brand
BENCO
Company
BENCO DENTAL SUPPLY CO.
Model
4130-567
Published
2022-08-05
Public version status
New
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
00366975052773PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00366975052773003669750527733669750527730366975052773

GMDN Terms#

Term, Definition table
TermDefinition
Custom-made mouthguardA custom-made oral device designed to protect the teeth, bones, and tissues of the mouth from damage due to impact/trauma typically during contact sports, and/or to prevent teeth grinding/clenching (bruxism). It is custom-made for a specified patient from impressions of the dental arch. Some types are referred to as nightguards or bite raising appliances. 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
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
00840456207109JMUJMU DENTAL, INCEBH2026-07-09
00840456209332JMUJMU DENTAL, INCEBH2026-07-09
00840456209349JMUJMU DENTAL, INCEBH2026-07-09
00840456209356JMUJMU DENTAL, INCEBH2026-07-09
00840456214138JMUJMU DENTAL, INCEBH2026-07-09
00840456214145JMUJMU DENTAL, INCEBH2026-07-09
00840456214152JMUJMU DENTAL, INCEBH2026-07-09
00840456214169JMUJMU DENTAL, INCEBH2026-07-09
00840456214176JMUJMU DENTAL, INCEBH2026-07-09
00840456214183JMUJMU DENTAL, INCEBH2026-07-09
00840456214190JMUJMU DENTAL, INCEBH2026-07-09
00840456214206JMUJMU DENTAL, INCEBH2026-07-09
00840456214213JMUJMU DENTAL, INCEBH2026-07-09