FDA.reportPublic FDA data

HuFriedyGroup

Primary DI
10889950143541
Brand
HuFriedyGroup
Company
HU-FRIEDY MFG. CO., LLC
Model
D-APPAIR
Device description
DEMO-PWR Pair Combo Unit
Published
2024-07-17
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
KOJAIRBRUSH

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KOJAirbrushDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K231391000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231391000Combi TouchMectron S.P.A.2023-05-15ELC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10889950143541PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088995014354110889950143541

GMDN Terms#

Term, Definition table
TermDefinition
Ultrasonic dental scaling/debridement systemAn assembly of mains electricity (AC-powered) devices intended to apply ultrasonic oscillations to: 1) mechanically fragment and dislodge gross debris in the dental pulp canal during an endodontic procedure; and/or 2) remove accretions from tooth surfaces during dental cleaning/periodontal therapy. The system typically consists of a generator with controls (e.g., foot-switch) that produces and controls high frequency electric current, and may provide fluid irrigation; a handpiece used to convert the energy to ultrasonic oscillations; and a tip(s) intended to apply the oscillations to the procedure site; tip selection typically affects the intended application (endodontic vs periodontal).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)483-7433info@hu-friedy.com

Regulatory Flags#

DUNS number
005085972
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800012410970Hu-FriedySSC-ULD22024-10-14
08800012410987Hu-FriedySSC-ULD32024-10-14
08800012410994Hu-FriedySSC-ULD42024-10-14
08800012411014Hu-FriedySSC-ULD62024-10-14
08800012411021Hu-FriedySSC-ULD72024-10-14
08800012411045Hu-FriedySSC-URD32024-10-14
08800012411052Hu-FriedySSC-URD42024-10-14
08800012411069Hu-FriedySSC-URD52024-10-14
08800012411076Hu-FriedySSC-URD62024-10-14
08800012411083Hu-FriedySSC-URD72024-10-14
08800012411090Hu-FriedySSC-LLD22024-10-14
08800012411106Hu-FriedySSC-LLD32024-10-14
08800012411113Hu-FriedySSC-LLD42024-10-14
08800012411120Hu-FriedySSC-LLD52024-10-14
08800012411137Hu-FriedySSC-LLD62024-10-14
08800012411144Hu-FriedySSC-LLD72024-10-14
08800012411151Hu-FriedySSC-LRD22024-10-14
08800012411168Hu-FriedySSC-LRD32024-10-14
08800012411175Hu-FriedySSC-LRD42024-10-14
08800012411274Hu-FriedySSC-URE22024-10-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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04560264548459Powder Handpiece(For Prophy use)NAKANISHI INC.KOJ2026-06-11
04560264548473Powder Handpiece(For Perio use)NAKANISHI INC.KOJ2026-06-11
04560264579538CLM Bottole SetNAKANISHI INC.KOJ2026-06-11
04560264579569CLM HolderNAKANISHI INC.KOJ2026-06-11
04589551391202Prophy Kit2NAKANISHI INC.KOJ2026-06-11
04589551391219Perio Kit2NAKANISHI INC.KOJ2026-06-11
04589551395095Varios Combi Pro2 Basic SetNAKANISHI INC.KOJ2026-06-11
04589551395323CLM Module SetNAKANISHI INC.KOJ2026-06-11
04589551395347Water Bottle KitNAKANISHI INC.KOJ2026-06-11
04589551395439FC-83NAKANISHI INC.KOJ2026-06-11
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00840479201313ETCHMASTERRELIANCE ORTHODONTIC PRODUCTS INCKOJ2026-03-04
00840479202587ETCHMASTERRELIANCE ORTHODONTIC PRODUCTS INCKOJ2026-03-04
07613353225940GBT FLOWCONTROL x 4E.M.S. Electro Medical Systems S.A.KOJ2026-02-16
07613353313500GBT Machine StationE.M.S. Electro Medical Systems S.A.KOJ2026-02-16
07613353331184GBT Machine Wireless PedalE.M.S. Electro Medical Systems S.A.KOJ2026-02-16
07613353334925AIR-FLOWE.M.S. Electro Medical Systems S.A.KOJ2026-02-16
07613353348137AIR-FLOWE.M.S. Electro Medical Systems S.A.KOJ2026-02-16