FDA.report

Safco Maxim K Files and Hedstrom

Primary DI
D72310272880
Brand
Safco Maxim K Files and Hedstrom
Company
SAFCO DENTAL SUPPLY CO.
Model
1027288
Catalog number
1027288
Device description
Safco Maxim Hedstrom #80 25mm 6/box
Published
2022-06-24
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
false

Related Records

Product Codes

CodeName
EKSFILE, PULP CANAL, ENDODONTIC

Product Code Classifications

CodeDeviceSpecialtyClass
EKSFile, Pulp Canal, EndodonticDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D72310272883PrimaryHIBCC0
D72310272880Unit of UseHIBCC0

GMDN Terms

TermDefinition
Endodontic instrument-holding insert, single-useA device intended to be fitted into an endodontic instrument holder housing and used chairside during a dental endodontic procedure to hold and temporarily store sharp endodontic instruments (e.g., files/rasps). It is in the form of a spongy foam insert into which the sharp end of instruments is inserted, thereby reducing risk of injury. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
020417380
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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