FDA.reportPublic FDA data

BENCO

Primary DI
00366975015280
Brand
BENCO
Company
BENCO DENTAL SUPPLY CO.
Model
1037-432
Device description
Tofflemire Matrix Retainer, Junior - Ca (72-30B)
Published
2018-10-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JEPRetainer, Matrix

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JEPRetainer, MatrixDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00366975015280PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00366975015280003669750152803669750152800366975015280

GMDN Terms#

Term, Definition table
TermDefinition
Dental matrix band retainerA dental device designed to engage the ends of a matrix band or strip to hold it in position around a tooth that is being prepared for a dental restoration. It can be designed as a self-closing circular ring, or a rod-like instrument that tensions and locks the matrix band in place. This device will remain intraoral or attached to the matrix band during the dental procedure. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
570-602-6924jsoroka@benco.com

Regulatory Flags#

DUNS number
015108087
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00366975000880MINIBLASTER4696-3222016-09-23
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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00883205044624Halo Sectional Matrix SystemULTRADENT PRODUCTS, INC.JEP2026-06-26
00883205044631Halo Sectional Matrix SystemULTRADENT PRODUCTS, INC.JEP2026-06-26
00883205044648Halo Sectional Matrix SystemULTRADENT PRODUCTS, INC.JEP2026-06-26
00883205044655Halo Sectional Matrix SystemULTRADENT PRODUCTS, INC.JEP2026-06-26
00883205040404Halo Sectional Matrix SystemULTRADENT PRODUCTS, INC.JEP2026-06-25
G149TBSB1380TBS BASICSACME ENTERPRISE.JEP2026-05-20
G149TBSB1420TBS BASICSACME ENTERPRISE.JEP2026-05-20
G149TBSB1430TBS BASICSACME ENTERPRISE.JEP2026-05-20
10304040193904Henry ScheinHENRY SCHEIN, INC.JEP2025-10-15
10304040193911Henry ScheinHENRY SCHEIN, INC.JEP2025-10-15
10304040193928Henry ScheinHENRY SCHEIN, INC.JEP2025-10-15
10304040193935Henry ScheinHENRY SCHEIN, INC.JEP2025-10-15
20686864061155MEDICOM SAFEMATRIXAMD Medicom IncJEP2025-03-18
10686864060649MEDICOM SAFEMATRIXAMD Medicom IncJEP2024-04-09
10686864060656MEDICOM SAFEMATRIXAMD Medicom IncJEP2024-04-09
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