FDA.reportPublic FDA data

SABLE 20K Air Motor

Primary DI
00841359030054
Brand
SABLE 20K Air Motor
Company
Sable Industries Inc
Model
1600111
Device description
NSK Type 20K mini Air Motor
Published
2022-12-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EFBHandpiece, Air-Powered, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EFBHandpiece, Air-Powered, DentalDental1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K083101000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K083101000PREMIUM SLOW SPEED; 20K AIR MOTOR, HEADS, CONTRA-ANGLES, STRAIGHT NOSECONESSable Industries, Inc.2009-02-23EFB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841359030054PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841359030054008413590300548413590300540841359030054

GMDN Terms#

Term, Definition table
TermDefinition
Dental surgical power tool motor, pneumaticA hand-held, pneumatically-powered component of a surgical power tool assembly designed to convert the energy from a compressed gas source [e.g., surgical-grade air or nitrogen (N2)] into a non-dedicated mechanical energy for drilling or sawing during dental surgery. It is designed to accept handpiece components/attachments (not included) and is not intended to directly accept an endpiece (e.g., drill bit, saw blade). It might be operated with a hand- or foot-switch. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
1-800-368-8106info@sableindustriesinc.com

Regulatory Flags#

DUNS number
255407272
Device count
1
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841359020185Access Prophy16003052024-06-21
00841359040138SABLE M-Style16005032022-07-28
00841359040190SABLE M-Style16005012022-07-28
00841359040206SABLE M-Style16005022022-07-28
00841359040220SABLE M-Style16005042022-07-28
00841359040268SABLE M-Style16005072022-07-28
00841359020031SABLE M-Style16002042022-07-11
00841359020130SABLE M-Style16003022022-07-11
00841359040046SABLE U-Type13003032023-02-08
00841359060105SABLE - Doctor's Package16000232022-09-28
00841359060112SABLE - Doctor's Package16000242022-09-28
00841359060129SABLE - Hygienist Package16000252022-09-28
00841359060136SABLE - Hygienist Package16000262022-09-28
00841359060013SABLE - Doctor's Package16000082022-07-29
00841359060020SABLE - Doctor's Package16000092022-07-29
00841359060037SABLE - Doctor's Package16000102022-07-29
00841359060044SABLE - Hygienist Package16000112022-07-29
00841359060051SABLE - Hygienist Package16000122022-07-29
00841359060068SABLE - Hygienist Package16000132022-07-29
00841359060075SABLE - Hygienist Package16000142022-07-29

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