FDA.reportPublic FDA data

Impact Air 45®

Primary DI
00851213006002
Brand
Impact Air 45®
Company
Vista Dental
Model
401
Device description
Fiberoptic high-speed handpiece
Published
2020-04-20
Public version status
Update
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
K952927000
K972375000
K972376000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K952927000IMPACT AIR 45 4-HOLEPalisades Pharmaceutics, Inc.1996-08-06EFB
K972375000IMPACT AIR 45 HANDPIECE FOR ENDODONTIC USEGlenwood, LLC1997-09-10EFB
K972376000IMPACT AIR 45 HANDPIECE FOR PERIODONTAL USEGlenwood, LLC1997-09-10EFB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851213006002PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851213006002008512130060028512130060020851213006002

GMDN Terms#

Term, Definition table
TermDefinition
Dental power tool system handpiece, pneumaticA hand-held dental device that includes a chuck for attaching a rotary dental endpiece (e.g., drill bits, burs, reamers) intended to be used in dentistry to bore/excavate bones, teeth, and tough tissues. The device incorporates a small turbine motor normally driven by compressed air, and which typically has a built-in water spray for cooling the rotating device; the endpiece(s) are not included. The handpiece is typically connected through the dental delivery system or a freestanding independent system. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
800-664-8000info@palisadesdental-llc.com

Regulatory Flags#

DUNS number
036623932
Device count
1
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10818207025170Fluorescent In Office Whitening Kit5042902026-07-20
00850194007763Zr-P Bottle905772026-06-04
00818207020840ZrP Syringe Kit905782021-01-29
10818207024920Endo Sealer Solvent3170332026-04-22
10818207024944Endo Sealer Solvent Sample317033-M2026-04-22
00850194007862Desensify12019-12-13
00850194007893Omni Etch Ceramic Etch and Silane12019-12-13
10818207024937EdgeUtopi BC Solvent 108182070249372025-03-17
10818207025071Endocator Starter Kit4077302025-11-07
10818207025088Endocator Swabs (20pk)4077312025-11-07
10818207025064ReminGelRGEL30002025-10-09
10818207020205Vista-Cal Standard Kit5026002018-07-31
10818207020878Velvet Etch 5033152021-05-13
30818207020872Velvet Etch 5033002021-05-13
00850194007787Purify+ Gel 5 Pack12019-12-13
00850194007794Purify+ Liquid 5 Pack12019-12-13
00850194007954Purify+ Gel Single Pack12019-12-13
00850194007961Purify+ Liquid Single Pack12019-12-13
20818207020202Vista-Cal Refill Kit5026012018-07-31
00850194007466RE-GEN Cleanser1907192016-06-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D950133802360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950133812360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950133822360Xtreme PowerLARES RESEARCHEFB2026-09-04
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
J0071602490011HOSE MX2 400 GREY_102646BIEN-AIR PORTUGAL, UNIPESSOAL, LDAEFB2026-08-27
07613353240011AIR-FLOWE.M.S. Electro Medical Systems S.A.EFB2026-07-21
07613353046897AIR-FLOW® PERIO handy 3.0 PERIO handpieceE.M.S. Electro Medical Systems S.A.EFB2026-07-14
07613353239992AIR-FLOW Handpiece 120°E.M.S. Electro Medical Systems S.A.EFB2026-07-14
07613353240134PERIO-FLOW HandpieceE.M.S. Electro Medical Systems S.A.EFB2026-07-14
07613353312558AIR-FLOW® PLUS handy 3.0 PERIO handpieceE.M.S. Electro Medical Systems S.A.EFB2026-07-14