FDA.report

SCOTT'S ECONOMY P/A SNAP TYPE

Primary DI
D77813515150
Brand
SCOTT'S ECONOMY P/A SNAP TYPE
Company
SCOTT'S DENTAL SUPPLY L.L.C.
Model
135-1515
Catalog number
135-1515
Device description
ECONOMY PROPHY ANGLE (1/pack) Type: Snap, Material: Stainless steel; For more information: https://www.scottsdental.com/metal-reusable-prophy-angles.html
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
false

Related Records

Product Codes

CodeName
EGSHandpiece, contra- and right-angle attachment, dental

Product Code Classifications

CodeDeviceSpecialtyClass
EGSHandpiece, Contra- And Right-Angle Attachment, DentalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D77813515150PrimaryHIBCC0

GMDN Terms

TermDefinition
Dental power tool converter attachment, rotaryA dental attachment, commonly known as a ratchet adaptor, drive converter, or dental turbine, designed to be fitted in a dental power tool handpiece to convert energy (e.g., electrical, pneumatic) to a rotational mechanical motion to achieve a specific function [e.g., drilling] during dental or orthodontic procedures. It is not an endpiece; an appropriate interchangeable endpiece (e.g., drill bit, dental bur) is intended to be fixed to the working end of this device. This is a reusable device.

Sterilization Methods

Method

Contacts

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

Regulatory Flags

DUNS number
137217043
Device count
1
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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