FDA.reportPublic FDA data

TOFFLEMIRE MATRIX RETAINERS JUNIOR, alone

Primary DI
07640159162247
Brand
TOFFLEMIRE MATRIX RETAINERS JUNIOR, alone
Company
Produits dentaires S.A.
Model
41504
Device description
The Tofflemire matrix retainer exists in 3 different size/configuration (Universal, Junior, Senior). Tofflemire matrix bands Assortments exist including retainers and bands or different bands configurations.Box
Published
2022-06-29
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
07640159162247PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640159162247076401591622477640159162247

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

Contacts#

Phone, Email table
PhoneEmail
+41219212631info@pd-dental.com

Regulatory Flags#

DUNS number
480420090
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07640159162711ROSEN ROOT-CANAL CEMENT102452022-06-15
07640159162728Eugenol - 15ml114202022-06-15
07640159162735Eugenol - 30 ml114212022-06-15
07640159162742Eugenol - 100 ml114222022-06-15
07640159162759ZINC OXIDE - 500g114302022-06-15
07640159162766ZINC OXIDE - 100g114312022-06-15
07640159162773ZINC OXIDE - 250g114322022-06-15
07640159162780ZINC OXIDE - 1'000g114332022-06-15
07640159162704EssenSeal10246EssenSeal2022-06-13
07640159163350Drill-A-Post - N°1225112023-05-24
07640159163367Drill-A-Post - N°2225122023-05-24
07640159163374Drill-A-Post - N°3225132023-05-24
07640159163381Drill-A-Post - N°4225142023-05-24
07640159163398Drill-A-Post - N°1 - Rack of 6 pieces225012023-05-24
07640159163404Drill-A-Post - N°2 - Rack of 6 pieces225022023-05-24
07640159163411Drill-A-Post - N°3 - Rack of 6 pieces225032023-05-24
07640159163428Drill-A-Post - N°4 - Rack of 6 pieces225042023-05-24
07640159160076HOOKED NEEDLE N. 1 RED202642022-06-21
07640159160083HOOKED NEEDLE N. 2 BLUE202652022-06-21
07640159160359CLASSIC NEEDLE N. 0 YELLOW202202022-06-21

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10304040193911Henry ScheinHENRY SCHEIN, INC.JEP2025-10-15
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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
10810038090495Strata-G™GARRISON DENTAL SOLUTIONS, L.L.C.JEP2023-02-14
10810038090501Strata-G™ GARRISON DENTAL SOLUTIONS, L.L.C.JEP2023-02-14
10810038090518Strata-G™ GARRISON DENTAL SOLUTIONS, L.L.C.JEP2023-02-14
10810038090525Strata-G™ GARRISON DENTAL SOLUTIONS, L.L.C.JEP2023-02-14
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20810038090515Strata-G™ GARRISON DENTAL SOLUTIONS, L.L.C.JEP2023-02-14
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20810038090539Strata-G™ GARRISON DENTAL SOLUTIONS, L.L.C.JEP2023-02-14
M752ZZ14080STRADIS HEALTHCARESTRADIS MEDICAL, LLCJEP2022-04-29
10686864056482MEDICOM SAFEMATRIXAMD Medicom IncJEP2021-04-27
10686864056499MEDICOM SAFEMATRIX CONTOURAMD Medicom IncJEP2021-04-27
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10304040142803Henry ScheinHENRY SCHEIN, INC.JEP2021-03-12
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