FDA.reportPublic FDA data

TurboVue™

Primary DI
00810000522606
Brand
TurboVue™
Company
PARKELL, INC.
Model
DLH30TRI
Catalog number
DLH30TRI
Device description
TurboVue™ Triple-Bend Light-Transmitting Insert (Standard Flow)
Published
2018-09-21
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
ELCScaler, Ultrasonic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ELCScaler, UltrasonicDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810000522606PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810000522606008100005226068100005226060810000522606

GMDN Terms#

Term, Definition table
TermDefinition
Ultrasonic dental scaling/debridement system handpiece tip, periodontalAn insert intended to be attached to an ultrasonic dental scaling/debridement system handpiece, to transmit ultrasonic energy (e.g., 25 kHz/30 kHz) from a generator to the oral cavity for the removal of accretions from tooth surfaces during dental cleaning or periodontal therapy; it is not intended for endodontic use. This device vibrates at a high frequency to provide the scaling effect. Water or a rinsing solution (e.g., chlorhexidine) is intended to be fed through the handpiece/tip assembly to assist in the process. This device is available in a variety of designs and tip shapes. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-18 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
6312491134customerservice@parkell.com

Regulatory Flags#

DUNS number
009900424
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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

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00810000528271TriPhasix™S408S4082025-09-26
0081000052669720/20™S575S5752025-09-26
00810000522934DuraTip®DURA30-PSLDURA30-PSL2025-07-18
00810000522941DuraTip®DURA30-PSRDURA30-PSR2025-07-18
00810000525751HyperFIL®S236S2362025-03-28
00810000525768HyperFIL®S237S2372025-03-28
00810000525775HyperFIL®S238S2382025-03-28
10810000520319Integra™D681D6812018-11-16
00810000521579PureClarity™D719D7192024-12-13
00810000521647PureClarity™D718D7182024-12-13
00810000525744OTCS833S8332024-06-28
10810000525086Dryz™S180S1802018-09-21
00810000525720HyperFIL®S234S2342024-03-01
00810000525737HyperFIL®S235S2352024-03-01
1081000052758520/20™S475S4752019-08-30
10810000524409Cinch™S469S4692019-07-26
10810000524416Cinch™S470S4702019-07-26
10810000524133Mach-2®S433S433S2018-10-19
10810000524157Blu-Mousse®S437SS437S2018-10-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810126506238Dream By 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCELC2026-03-05
00810126506245Dream By 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCELC2026-03-05
00810126506252Dream By 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCELC2026-03-05
00810126506269Dream By 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCELC2026-03-05
00810126506276Dream By 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCELC2026-03-05
00810126506283Dream By 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCELC2026-03-05
00810126506290Dream By 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCELC2026-03-05
00810126506306Dream By 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCELC2026-03-05
00810126506313Dream by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCELC2026-03-05
00810126506320Dream By 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCELC2026-03-05
07613353180089Instruments A P PSE.M.S. Electro Medical Systems S.A.ELC2026-02-16
07613353180096Instruments PS PSR PSLE.M.S. Electro Medical Systems S.A.ELC2026-02-16
07613353335847AIR-FLOWE.M.S. Electro Medical Systems S.A.ELC2026-02-16
07613353336837Instruments PSR PSLE.M.S. Electro Medical Systems S.A.ELC2026-02-16
07613353347802GBT Machine AIRFLOW Prophylaxis MasterE.M.S. Electro Medical Systems S.A.ELC2026-02-16
07613353347819GBT Machine AIRFLOW Prophylaxis MasterE.M.S. Electro Medical Systems S.A.ELC2026-02-16
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04589551387168Tip Cover LNAKANISHI INC.ELC2026-01-21
04589551387151Tip Cover SNAKANISHI INC.ELC2026-01-21
04589551382828E TIP WRENCHNAKANISHI INC.ELC2026-01-21
04589551387144VariosNAKANISHI INC.ELC2026-01-21
04560264579958CLA-10NAKANISHI INC.ELC2026-01-21
045895513889743 Mode Select SwitchNAKANISHI INC.ELC2026-01-21