FDA.reportPublic FDA data

SABLE - Hygienist Package

Primary DI
00841359060099
Brand
SABLE - Hygienist Package
Company
Sable Industries Inc
Model
1600018
Device description
SABLE Ball Bearing Screw In E-Type Hygienist Package.Package contains: Air Motor(1600110), 4:1 Contra Angle(1600212)
Published
2022-07-29
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
EGSHandpiece, Contra- And Right-Angle Attachment, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EFBHandpiece, Air-Powered, DentalDental1
EGSHandpiece, Contra- And Right-Angle Attachment, 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
00841359060099PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841359060099008413590600998413590600990841359060099

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
Kit
true
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
00841359030054SABLE 20K Air Motor16001112022-12-01
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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D950133832360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950133842360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950133852360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950133902360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950133912360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950133922360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950133932360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950133942360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950133952360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950134802360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950134812360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950134822360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950134832360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950134842360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950134852360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950134902360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950134912360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950134922360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950134932360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950134942360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950134952360Xtreme PowerLARES RESEARCHEFB2026-09-04
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