FDA.report

Patterson

Primary DI
D6620708721920
Brand
Patterson
Company
PATTERSON DENTAL SUPPLY, INC.
Model
087-2192
Catalog number
70872192
Device description
FILE, PULP CANAL, ENDODONTIC
Published
2024-11-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
EKSFILE, PULP CANAL, ENDODONTIC

Product Code Classifications

CodeDeviceSpecialtyClass
EKSFile, Pulp Canal, EndodonticDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D6620708721921PrimaryHIBCC0
D6620708721920Unit of UseHIBCC0

GMDN Terms

TermDefinition
Dental restoration carver, amalgam, single-useA hand-held manual dental instrument intended to be used for producing and perfecting anatomical forms in dental amalgam restorations, typically by cutting, scraping, paring, and smoothing finishes and modelling patterns intraorally. It will typically be a double-ended instrument with working ends of various shapes and designs, and a central handle. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
171843584
Device count
6
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
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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D6620708508002Patterson®70850800708508002016-09-23
D6620703523022Patterson®70352302703523022016-09-23
D6620704114962Patterson®70411496704114962016-09-23
D6620704115042Patterson®70411504704115042016-09-23
D6620704115122Patterson®70411512704115122016-09-23
D6620704115202Patterson®70411520704115202016-09-23
D6620704115382Patterson®70411538704115382016-09-23
D6620704115462Patterson®70411546704115462016-09-23
D6620704115532Patterson®70411553704115532016-09-23
D6620704115790Patterson®70411579704115792016-09-23
D6620704115870Patterson®70411587704115872016-09-23

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