FDA.report

SCOTT'S ABSORBENT POINTS PT TAPER 100/bx CC # F2

Primary DI
D77810392120
Brand
SCOTT'S ABSORBENT POINTS PT TAPER 100/bx CC # F2
Company
SCOTT'S DENTAL SUPPLY L.L.C.
Model
103-9212
Catalog number
103-9212
Device description
ABSORBENT POINTS (100/box) Type: PT Taper, Size: F2; For more information: https://www.scottsdental.com/catalog/product/view/id/30500/s/tapered-asorbent-points-scott-s-select/
Published
2021-02-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
EKNPOINT, PAPER, ENDODONTIC

Product Code Classifications

CodeDeviceSpecialtyClass
EKNPoint, Paper, EndodonticDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D77810392121PrimaryHIBCC0
D77810392120Unit of UseHIBCC0

GMDN Terms

TermDefinition
Endodontic paper pointA non-medicated absorbent point used in endodontic procedures that has been sterilized once in a manner approved by the manufacturer. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)901-3368info@scottsdental.com

Regulatory Flags

DUNS number
137217043
Device count
100
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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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