FDA.report

SCOTT'S MICRO APPLICATORS 100/pk REGULAR

Primary DI
D77819910910
Brand
SCOTT'S MICRO APPLICATORS 100/pk REGULAR
Company
SCOTT'S DENTAL SUPPLY L.L.C.
Model
199-1091
Catalog number
199-1091
Device description
SCOTT'S MICRO APPLICATORS 100/pk REGULAR
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
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
KXRAPPLICATOR, RESIN

Product Code Classifications

CodeDeviceSpecialtyClass
KXRApplicator, ResinDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D77819910911PrimaryHIBCC0
D77819910910Unit of UseHIBCC0

GMDN Terms

TermDefinition
Dental material application tool, single-useA hand-held manual dental instrument intended to be used for the application of a dental restorative material (e.g., amalgam, resin) to a patient’s tooth/teeth; the restorative material is not included. It includes a handle with an application tip/brush which holds the material on its surface/bristles; it is not a syringe- or pistol-like device. 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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