FDA.reportPublic FDA data

PRO-SYS

Primary DI
00366975000149
Brand
PRO-SYS
Company
BENCO DENTAL SUPPLY CO.
Model
4737-877
Published
2022-08-04
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
EFWToothbrush, Manual

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EFWToothbrush, ManualDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00366975000149PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00366975000149003669750001493669750001490366975000149

GMDN Terms#

Term, Definition table
TermDefinition
Basic manual toothbrushAn instrument designed to be used by a patient to manually brush clean their teeth and gums (i.e., remove plaque, tartar, stains). It typically consists of a proximal handle and distal head with rows of bristles (e.g., nylon) grouped in separate tufts or evenly distributed. The device is typically used with toothpaste. 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
00366975013347FAS-TRACT4006-9062018-12-05
00366975001887BENCO3630-3312016-09-23
D74451864890BENCO5186-4892017-11-29
D74451864980BENCO5186-4982017-11-29
D74451865230BENCO5186-5232017-11-29
D74451865320BENCO5186-5322017-11-29
D74451865410BENCO5186-5412017-11-29
00366975001894BENCO3630-3682016-09-23
00366975001900BENCO3630-3862016-09-23
00366975001917BENCO3630-4022016-09-23
00366975032768BENCO3630-0552016-09-23
00366975070005Sterling5259-5162025-02-26
00366975069993Sterling6694-6422025-02-26
00366975058768BENCO5726-5832022-08-04
00366975003317BENCO3470-4242016-09-23
00366975003409BENCO3470-4152016-09-23
D744101162914Gibson Healthcare1011-6291011-6292015-10-22
D744101164714Gibson Healthcare1011-6471011-6472015-10-22
D74417597511Gibson Healthcare175975117597512017-02-13
D74419672861Gibson Healthcare1967-2861967-2862017-02-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00072239332559Dr. Brown'sDr. Brown's CompanyEFW2026-06-08
00072239332566Dr. Brown'sDr. Brown's CompanyEFW2026-06-08
00072239332573Dr. Brown'sDr. Brown's CompanyEFW2026-06-08
00072239332580Dr. Brown'sDr. Brown's CompanyEFW2026-06-08
00072239334812Dr. Brown'sDr. Brown's CompanyEFW2026-06-08
00072239334829Dr. Brown'sDr. Brown's CompanyEFW2026-06-08
00072239334836Dr. Brown'sDr. Brown's CompanyEFW2026-06-08
00072239328002Dr. Brown'sDr. Brown's CompanyEFW2026-06-05
00072239328149Dr. Brown'sDr. Brown's CompanyEFW2026-06-05
00072239330050Dr. Brown'sDr. Brown's CompanyEFW2026-06-05
00072239332313Dr. Brown'sDr. Brown's CompanyEFW2026-06-05
00072239332320Dr. Brown'sDr. Brown's CompanyEFW2026-06-05
00072239332535Dr. Brown'sDr. Brown's CompanyEFW2026-06-05
00072239332542Dr. Brown'sDr. Brown's CompanyEFW2026-06-05
00072239333129Dr. Brown'sDr. Brown's CompanyEFW2026-06-05
10889483565599BALLARD™SUNMED, LLCEFW2026-01-12
00070942007368GUM Technique Sensitive CleanSUNSTAR AMERICAS, INC.EFW2025-08-15
00070942007412GUM Technique Sensitive CleanSUNSTAR AMERICAS, INC.EFW2025-08-15
10304040192471Henry ScheinHENRY SCHEIN, INC.EFW2025-07-08
20371347019531Advance Dental ProductsThe Atlanta Dental Supply CompanyEFW2025-06-25
00072239331057Dr. Brown'sDr. Brown's CompanyEFW2025-05-23
00072239330418Dr. Brown'sDr. Brown's CompanyEFW2025-05-22
00070942006378GUM Technique Sensitive CleanSUNSTAR AMERICAS, INC.EFW2025-05-19
10810063756243KIDS BUDDY ToothbrushSAFCO DENTAL SUPPLY CO.EFW2025-03-19
10810063756250Power Curve ToothbrushSAFCO DENTAL SUPPLY CO.EFW2025-03-19
10810063756267Esprit Ultra Fine ToothbrushSAFCO DENTAL SUPPLY CO.EFW2025-03-19
10810063756274Whisper Tech Ultra-Fine ToothbrushSAFCO DENTAL SUPPLY CO.EFW2025-03-19
10810063756281Power Curve ToothbrushSAFCO DENTAL SUPPLY CO.EFW2025-03-19
10810063756403Power Curve Extra-Soft ToothbrushSAFCO DENTAL SUPPLY CO.EFW2025-03-19
10810063756434KIDS BUDDY ToothbrushSAFCO DENTAL SUPPLY CO.EFW2025-03-19