FDA.reportPublic FDA data

FLASH pearl

Primary DI
04560264513488
Brand
FLASH pearl
Company
NAKANISHI INC.
Model
FLASH pearl
Published
2022-08-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

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
K112673000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K112673000PROPHY-MATE NEONakanishi, Inc.2012-02-07EFB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04560264513488PrimaryGS10
04589551382774Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04560264513488045602645134884560264513488
04589551382774045895513827744589551382774

GMDN Terms#

Term, Definition table
TermDefinition
Professional dental abrasive materialA dental material made from various base substances having some abrasive qualities [e.g., treated sodium bicarbonate (NaHCO3) or aluminium oxide (Al2O3)] and applied by a healthcare professional with an appropriate device (e.g., a dental abrasive air jet system) to the surface of teeth or dental devices (e.g., restorations). It has a wide variety of both prophylactic and treatment applications such as the removal of plaque and stains, cleaning fissures (above and below the gingiva), the preparation of a tooth surface prior to bonding, cleaning orthodontic appliances (bands and brackets), removing adhesive residue, and cleaning implants prior to loading. This is a single-use device.

Regulatory Flags#

DUNS number
690710546
Device count
100
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04589551366217P300-2A100P300-2A1002026-06-26
04589551366262P300-2A120P300-2A1202026-06-26
04589551366316P300-2S100P300-2S1002026-06-26
04589551366361P300-2S120P300-2S1202026-06-26
04589551366422PD-IN-2-120PD-IN-2-1202026-06-26
04560264548459Powder Handpiece(For Prophy use)Powder Handpiece(For Prophy use)2026-06-11
04560264548473Powder Handpiece(For Perio use)Powder Handpiece(For Perio use)2026-06-11
04560264579538CLM Bottole SetCLM Bottle Set2026-06-11
04560264579569CLM HolderCLM Holder2026-06-11
04589551391202Prophy Kit2Prophy Kit22026-06-11
04589551391219Perio Kit2Perio Kit22026-06-11
04589551395095Varios Combi Pro2 Basic SetVarios Combi Pro2 Basic Set2026-06-11
04589551395323CLM Module SetCLM Module Set2026-06-11
04589551395347Water Bottle KitWater Bottle Kit2026-06-11
04589551395439FC-83FC-832026-06-11
04589551386758VA-SG-TIP HOLDERVA-SG-TIP HOLDER2026-04-08
04589551395088Multi Pad2Multi Pad22026-06-02
04589551366583Sterile Cutting ToolUBS-RD70C2-082026-05-22
04589551366590Sterile Cutting ToolUBS-RD70C2-072026-05-22
04589551366606Sterile Cutting ToolUBS-RD50C2-082026-05-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
J021112330111OS30W & H Dentalwerk Bürmoos GmbHEFB2024-07-03
J00715031850011NGO motor driverBien-Air Dental SAEFB2023-09-15
J021026904001MCA-RM-RQW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021026930001MCA-ISO-CKW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021031035001MCA-ISO-MWW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021052046001MCA-ISO-PLW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021060371001Universal Adapter VDWW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021111443001RC-43 Contra-Angle HandpieceW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021112458001RC-58 Contra-Angle HandpieceW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021301040001AM-25 A BC Air MotorW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021300960001PL-66 W Handpiece 4:1W & H Dentalwerk Bürmoos GmbHEFB2022-11-29
J021300970001PL-64 Handpiece 4:1W & H Dentalwerk Bürmoos GmbHEFB2022-11-29
J021300980001PL-44 Handpiece 4:1W & H Dentalwerk Bürmoos GmbHEFB2022-11-29
J021080649701One Care SetW & H Dentalwerk Bürmoos GmbHEFB2022-08-24