FDA.report

Reel Matrix™

Primary DI
00810038093161
Brand
Reel Matrix™
Company
GARRISON DENTAL SOLUTIONS, L.L.C.
Model
RM100D
Catalog number
RM100D
Device description
Matrix Band, Dead-Soft
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
true

Related Records

Contact Domains

Product Codes

CodeName
DZNInstruments, Dental Hand

Product Code Classifications

CodeDeviceSpecialtyClass
DZNInstruments, Dental HandDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10810038093168PrimaryGS10
00810038093161Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1081003809316810810038093168
00810038093161008100380931618100380931610810038093161

GMDN Terms

TermDefinition
Dental matrix band, single-useA band or strip of strong material (typically a transparent plastic) or a short tube that is used to form a mould around a tooth for the insertion of restorative materials. The device is typically held snugly around the tooth by a matrix retainer. This is a single-use device.

Device Sizes

TypeValueUnit
Height5Millimeter

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
888-437-0032gds@garrisondental.com

Regulatory Flags

DUNS number
057647005
Device count
50
DM exempt
true
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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06438311708713LMDentalLM-DentalDZN2026-03-23
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06438311708768LMDentalLM-DentalDZN2026-03-23
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