FDA.report

Impact Air 45®

Primary DI
00851213006019
Brand
Impact Air 45®
Company
PALISADES DENTAL L.L.C
Model
402
Device description
2 Hole high-speed handpiece
Published
2020-04-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
EFBHandpiece, Air-Powered, Dental

Product Code Classifications

CodeDeviceSpecialtyClass
EFBHandpiece, Air-Powered, DentalDental1

Premarket Submissions

SubmissionSupplement
K952927000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K952927000IMPACT AIR 45 4-HOLEPalisades Pharmaceutics, Inc.1996-08-06EFB

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00851213006019PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00851213006019008512130060198512130060190851213006019

GMDN Terms

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
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
800-664-8000info@palisadesdental-llc.com

Regulatory Flags

DUNS number
146844779
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00851213006002Impact Air 45®4012020-04-20
00851213006026Impact Air 45®4032020-04-20
00851213006033Impact Air 45®4072020-04-20
00851213006040Impact Air 45®4082020-04-20

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