FDA.reportPublic FDA data

Turbo Piezo™

Primary DI
00810000520398
Brand
Turbo Piezo™
Company
PARKELL, INC.
Model
D692
Catalog number
D692
Device description
Universal Straight Tip for Turbo Piezo™ Ultrasonic Scaler
Published
2018-11-16
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
00810000520398PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810000520398008100005203988100005203980810000520398

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.

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
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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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Primary DI, Brand, Model table
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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
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07613353335847AIR-FLOWE.M.S. Electro Medical Systems S.A.ELC2026-02-16
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