FDA.reportPublic FDA data

BENCO

Primary DI
00366975031723
Brand
BENCO
Company
BENCO DENTAL SUPPLY CO.
Model
5076-866
Published
2022-08-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
NRDUnit, Operative Dental, Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NRDUnit, Operative Dental, AccessoriesDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00366975031723PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00366975031723003669750317233669750317230366975031723

GMDN Terms#

Term, Definition table
TermDefinition
Medical equipment drape, single-useA flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or equipment components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the contents from soiling and contamination when used in the vicinity of, or entered into, a hygienic area. It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
015108087
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
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
00366975069993Sterling6694-6422025-02-26
00366975070005Sterling5259-5162025-02-26
00366975069344STERLING5259-507 2024-01-26
00366975013040STERLING5259-5072023-12-13
00366975012814STERLING4983-5662023-06-13
00366975066848OPTIMUM6032-0532023-02-21
00366975066855OPTIMUM6032-0712023-02-21
00366975066862OPTIMUM6032-0802023-02-21
00366975066879OPTIMUM6032-0992023-02-21
00366975066886OPTIMUM6032-1062023-02-21
00366975066893OPTIMUM6032-1152023-02-21
00366975066909OPTIMUM6032-1242023-02-21
00366975066916OPTIMUM6032-1332023-02-21
00366975066923OPTIMUM6032-1422023-02-21
00366975066930OPTIMUM6032-1512023-02-21
00366975066947OPTIMUM6032-1602023-02-21
00366975066954OPTIMUM6032-1792023-02-21
00366975066961OPTIMUM6032-1972023-02-21
00366975066978OPTIMUM6032-2042023-02-21
00366975066992OPTIMUM6032-2312023-02-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D12517802Premium PlusPremium Plus (Dongguan) LimitedNRD2026-05-22
D12517812Premium PlusPremium Plus (Dongguan) LimitedNRD2026-05-22
D12517822Premium PlusPremium Plus (Dongguan) LimitedNRD2026-05-22
00810126506511Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCNRD2025-12-16
00810126506528Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCNRD2025-12-16
00810126506535Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCNRD2025-12-16
00810126506559Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCNRD2025-12-16
00810126506573Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCNRD2025-12-16
00817169023708Essentials By 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCNRD2025-12-16
00371347017878Advance Dental ProductsThe Atlanta Dental Supply CompanyNRD2025-11-24
00371347017885Advance Dental ProductsThe Atlanta Dental Supply CompanyNRD2025-11-24
00371347017830Advance Dental ProductsThe Atlanta Dental Supply CompanyNRD2025-11-18
00371347017847Advance Dental ProductsThe Atlanta Dental Supply CompanyNRD2025-11-18
00371347017854Advance Dental ProductsThe Atlanta Dental Supply CompanyNRD2025-11-18
00371347017861Advance Dental ProductsThe Atlanta Dental Supply CompanyNRD2025-11-18
06971119541897Air compressor Guangdong JINME Medical Technology Co., Ltd.NRD2025-07-23
06971119541903Testing machineGuangdong JINME Medical Technology Co., Ltd.NRD2025-07-23
10194665007935ActeonA-DEC, INC.NRD2025-05-15
D1302HD40BaseVacR. E. Morrison Equipment IncNRD2025-05-14
D1303HD40BaseVacR. E. Morrison Equipment IncNRD2025-05-14
D1304HD40BaseVacR. E. Morrison Equipment IncNRD2025-05-14
D130BVM10BaseVacR. E. Morrison Equipment IncNRD2025-05-14
D130BVM20BaseVacR. E. Morrison Equipment IncNRD2025-05-14
D130HD40BaseVacR. E. Morrison Equipment IncNRD2025-05-14
D678AS50X1AirStarAIR TECHNIQUES, INC.NRD2025-04-25
D678AS70X0AirStarAIR TECHNIQUES, INC.NRD2025-04-25
00304040190371Henry ScheinHENRY SCHEIN, INC.NRD2025-03-21
00304040190388Henry ScheinHENRY SCHEIN, INC.NRD2025-03-21
00304040190395Henry ScheinHENRY SCHEIN, INC.NRD2025-03-21
00304040190401Henry ScheinHENRY SCHEIN, INC.NRD2025-03-21