FDA.reportPublic FDA data

TUN Ultrasonic Tip

Primary DI
00850440008612
Brand
TUN Ultrasonic Tip
Company
Engineered Endodontics, LLC
Model
GC3D
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
00850440008612PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850440008612008504400086128504400086120850440008612

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
07613353194963PIEZON Handpiece S5E.M.S. Electro Medical Systems S.A.ELC2026-07-14
07613353240950PIEZON Handpiece LEDE.M.S. Electro Medical Systems S.A.ELC2026-07-14
07613353257743AIR-FLOW-PIEZONE.M.S. Electro Medical Systems S.A.ELC2026-07-14
07613353311803Instrument PI starter kitE.M.S. Electro Medical Systems S.A.ELC2026-07-14
07613353318123GBT Machine Wireless PedalE.M.S. Electro Medical Systems S.A.ELC2026-07-14
07613353318581AIRFLOW Prophylaxis MasterE.M.S. Electro Medical Systems S.A.ELC2026-07-14
07613353334833GBT Machine AIRFLOW Prophylaxis MasterE.M.S. Electro Medical Systems S.A.ELC2026-07-14
07613353343408PIEZON Handpiece LEDE.M.S. Electro Medical Systems S.A.ELC2026-07-14
07613353028374PIEZONE.M.S. Electro Medical Systems S.A.ELC2026-07-13
07613353170318PIEZONE.M.S. Electro Medical Systems S.A.ELC2026-07-13
07613353170325PIEZONE.M.S. Electro Medical Systems S.A.ELC2026-07-13
07613353223182PIEZONE.M.S. Electro Medical Systems S.A.ELC2026-07-13
07613353225117PIEZONE.M.S. Electro Medical Systems S.A.ELC2026-07-13
J021304950011Foot control S-NW3W & H Dentalwerk Bürmoos GmbHELC2026-06-23
J021304970001Foot control S-N3W & H Dentalwerk Bürmoos GmbHELC2026-06-23
J021305040001Implantmed Plus II (SI-2100)W & H Dentalwerk Bürmoos GmbHELC2026-06-23
J021305050001Implantmed Plus II (SI-2101)W & H Dentalwerk Bürmoos GmbHELC2026-06-23
J021305060001Implantmed Plus II (SI-2102)W & H Dentalwerk Bürmoos GmbHELC2026-06-23
J021305070001Piezomed Module Plus II (SP-210 M)W & H Dentalwerk Bürmoos GmbHELC2026-06-23
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