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Acteon

FDA UDI

Class II (US FDA UDI)

by Satelec

Identity

Trade Name
ACTEON FDA UDI
Generic Name
Ultrasonic dental scaling/debridement system handpiece tip, periodontal FDA UDI
Device Name
Short Titanium-Niobium tip, length 15mm, taper 4% The ET25S (short) tip is designed for retreatment in the coronal third and the isthmuses. FDA UDI
Model / Reference
TIP ET25S FDA UDI
Description
Short Titanium-Niobium tip, length 15mm, taper 4% The ET25S (short) tip is designed for retreatment in the coronal third and the isthmuses. FDA UDI

Identifiers

Catalog Number
F88021 FDA UDI
Primary DI / UDI-DI
03609820880211 FDA UDI
FDA Product Code
ELC FDA UDI
GMDN Term
Ultrasonic dental scaling/debridement system handpiece tip, periodontal FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.4850 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Ultrasonic dental scaling/debridement system handpiece tip, periodontal

Acteon by Satelec — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ultrasonic dental scaling/debridement system handpiece tip, periodontal.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Satelec

Sources (1)

  • FDA UDI bac76206-a786-4394-a47b-3c3a8eec15ea 35 fields · synced May 30, 2026