FDA.report

Reel Matrix™

Primary DI
00810038096049
Brand
Reel Matrix™
Company
GARRISON DENTAL SOLUTIONS, L.L.C.
Model
RMK04
Catalog number
RMK04
Device description
System Kit: (60) SuperCap Matrices, (1) Matrix Tensioning Instrument, (1) Small PerForm™ Proximal Contact Instrument, (1) Large PerForm™ Proximal Contact Instrument
Published
2020-04-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
DZNInstruments, Dental Hand

Product Code Classifications

CodeDeviceSpecialtyClass
DZNInstruments, Dental HandDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810038096049PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810038096049008100380960498100380960490810038096049

GMDN Terms

TermDefinition
Dental matrix band kitA collection of non-sterile devices intended for the temporary introduction of a dental matrix band to form a mould around a tooth prior to tooth restoration using a direct restorative material (not included). Often referred to as a dental matrix system, it includes a matrix band(s), matrix band tensioner, dental wedge, and appropriate forceps. This device is reusable after appropriate cleaning/sterilization of the reusable instruments, and when the consumable products have been replenished.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
888-437-0032gds@garrisondental.com

Regulatory Flags

DUNS number
057647005
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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
true

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