FDA.reportPublic FDA data

TUN Ultrasonic Tip

Primary DI
00850440008773
Brand
TUN Ultrasonic Tip
Company
Engineered Endodontics, LLC
Model
GK5D
Device description
TUN Ultrasonic Tip
Published
2026-01-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
ELCScaler, Ultrasonic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ELCScaler, UltrasonicDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K182145000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182145000tün® ultrasonic tips product familyEngineered Endodontics2019-06-07ELC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850440008773PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850440008773008504400087738504400087730850440008773

GMDN Terms#

Term, Definition table
TermDefinition
Ultrasonic dental scaling/debridement system handpiece tip, endodonticAn 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 fragment and dislodge the debris within the dental pulp for removal during an endodontic procedure; it is not primarily intended for dental cleaning or periodontal therapy. Also referred to as an ultrasonic endodontic file or rasp, it is available in a variety of forms and sizes, and is typically made of metal. This is a reusable device.

Sterilization Methods#

Method table
Method
Dry Heat Sterilization

Regulatory Flags#

DUNS number
079892178
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850440008001TUN Ultrasonic TipE12026-01-02
00850440008025TUN Ultrasonic TipE22026-01-02
00850440008049TUN Ultrasonic TipE32026-01-02
00850440008063TUN Ultrasonic TipE42026-01-02
00850440008087TUN Ultrasonic TipE52026-01-02
00850440008100TUN Ultrasonic TipE62026-01-02
00850440008124Finishing File2004212026-01-02
00850440008131Finishing File2004252026-01-02
00850440008148Finishing File2004312026-01-02
00850440008254TUN Ultrasonic TipR12026-01-02
00850440008278TUN Ultrasonic TipR22026-01-02
00850440008292TUN Ultrasonic TipR32026-01-02
00850440008339IrriGatorESIT30222026-01-02
00850440008346IrriGatorESIT30262026-01-02
00850440008353IrriGatorESITPR272026-01-02
00850440008360IrriGatorESITPR302026-01-02
00850440008377IrriGatorESITPL272026-01-02
00850440008384IrriGatorESITPL302026-01-02
00850440008391ES Cap TipsESCAP2026-01-02
00850440008407EDTAESEDTA2026-01-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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07630392912624BioSonicDent4You AGELC2026-04-06
07630392912631BioSonicDent4You AGELC2026-04-06
07630392912648BioSonicDent4You AGELC2026-04-06
07613353352356GBT Machine AIRFLOW Prophylaxis MasterE.M.S. Electro Medical Systems S.A.ELC2026-02-24
07613353313500GBT Machine StationE.M.S. Electro Medical Systems S.A.ELC2026-02-16
10889950154066PWR AirHU-FRIEDY MFG. CO., LLCELC2026-01-14
10889950154080HuFriedyGroupHU-FRIEDY MFG. CO., LLCELC2026-01-14
10889950154103HuFriedyGroupHU-FRIEDY MFG. CO., LLCELC2026-01-14
07613353335113PIEZONE.M.S. Electro Medical Systems S.A.ELC2025-10-21
07613353341404PiezonE.M.S. Electro Medical Systems S.A.ELC2025-10-21
07613353257224AIR-FLOW-PIEZONE.M.S. Electro Medical Systems S.A.ELC2025-10-20
07613353257323AIR-FLOW-PIEZONE.M.S. Electro Medical Systems S.A.ELC2025-10-20
07613353257576AIR-FLOW-PIEZONE.M.S. Electro Medical Systems S.A.ELC2025-10-20
07613353258061AIR-FLOWE.M.S. Electro Medical Systems S.A.ELC2025-10-20
10810000520630Parkell®PARKELL, INC.ELC2023-10-20
10810000521552Parkell®PARKELL, INC.ELC2023-10-20
J021303230001Proxeo ULTRA PB-510W & H Dentalwerk Bürmoos GmbHELC2023-07-19
J021303240001Proxeo ULTRA PB-520W & H Dentalwerk Bürmoos GmbHELC2023-07-19
J021303250001Proxeo ULTRA PB-530W & H Dentalwerk Bürmoos GmbHELC2023-07-19
J021303260001Proxeo ULTRA Handpiece PB-5 LW & H Dentalwerk Bürmoos GmbHELC2023-07-19
J021303270001Proxeo ULTRA Handpiece PB-5 L QW & H Dentalwerk Bürmoos GmbHELC2023-07-19
J021303280001Proxeo ULTRA Handpiece PB-5 L SW & H Dentalwerk Bürmoos GmbHELC2023-07-19
J021303530001MC-2.0 I (Motorcontroller Implantology)W & H Dentalwerk Bürmoos GmbHELC2023-07-19
J021303580001Perestaltic Pump W & H Dentalwerk Bürmoos GmbHELC2023-07-19
J021303630001EXP-PD-ST-00 (Pump Controller)W & H Dentalwerk Bürmoos GmbHELC2023-07-19
J021303440001APP-HC-03-XX-00 (Head Controller)W & H Dentalwerk Bürmoos GmbHELC2023-07-19
J021303470001IFB-DC-CO.CO-HS-00 (Interface Board)W & H Dentalwerk Bürmoos GmbHELC2023-07-19
J021303480001RFB-03-0200-00 (Rectifier-Board)W & H Dentalwerk Bürmoos GmbHELC2023-07-19
J021302780001MC-1.0 and AD-1.0 Analog MotorcontrollerW & H Dentalwerk Bürmoos GmbHELC2023-07-11