FDA.reportPublic FDA data

Impact Air 45®

Primary DI
00851213006040
Brand
Impact Air 45®
Company
Vista Dental
Model
408
Device description
Non-Optic Quick Disconnect 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
00851213006040PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851213006040008512130060408512130060400851213006040

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

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Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
07613353344238PERIO-FLOW HandpieceE.M.S. Electro Medical Systems S.A.EFB2026-07-14
00840456222843JMUJMU DENTAL, INCEFB2026-06-25
00840456222850JMUJMU DENTAL, INCEFB2026-06-25
00810021439778DCI EdgeDCI International, LLCEFB2026-06-01
00810021439785DCI EdgeDCI International, LLCEFB2026-06-01
07640397422028Statcare sprayDent4You AGEFB2026-04-24
07640397422035Statmatic sprayDent4You AGEFB2026-04-24
J021020835001MCA-RM-BCW & H Dentalwerk Bürmoos GmbHEFB2025-12-02
J0071600436001USA1PM 1:2Bien-Air Dental SAEFB2025-10-13
J0071600052001USA1PM 1:1 EXT SPRAYBien-Air Dental SAEFB2025-10-10
J0071600692001USA1CA 20:1 L MICRO-SERIESBien-Air Dental SAEFB2025-10-10
J0071601136001USA1CA NOVA 1:1L MSBien-Air Dental SAEFB2025-10-10
J0071601138001USA1CA NOVA 1:5L MSBien-Air Dental SAEFB2025-10-10
07613353342067AIR-FLOWE.M.S. Electro Medical Systems S.A.EFB2025-07-07
07613353342074AIR-FLOWE.M.S. Electro Medical Systems S.A.EFB2025-07-07
J021300850001WG-67 AW & H Dentalwerk Bürmoos GmbHEFB2025-03-04
J021300740001TE-95 BC TurbineW & H Dentalwerk Bürmoos GmbHEFB2024-07-29
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