FDA.report

Composi-Tight®

Primary DI
00810038095646
Brand
Composi-Tight®
Company
GARRISON DENTAL SOLUTIONS, L.L.C.
Model
FXR-KFF-14
Catalog number
FXR-KFF-14
Device description
3D Fusion™ Sectional Matrix System: (70) Full Curve Matrices, (80) Wedges, (4) FenderWedge®, (12) Rally™ Polishers, (1) Short Ring, (1) Tall Ring, (1) Wide Prep Ring, (1) Ring Placement Forceps, (1) Matrix Forceps
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
JEPRetainer, Matrix

Product Code Classifications

CodeDeviceSpecialtyClass
JEPRetainer, MatrixDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810038095646PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810038095646008100380956468100380956460810038095646

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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