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PURE DentA

FDA UDI

Class II (US FDA UDI)

by Endymed Medical Ltd

Identity

Trade Name
PURE DentA FDA UDI
Generic Name
Multi-modality skin/body contouring system FDA UDI
Device Name
The ENDYMED PURE DentA is a device intended for use in Dermatologic and General Surgical Procedures. FDA UDI
Model / Reference
PURE DentA 110V FDA UDI
Description
The ENDYMED PURE DentA is a device intended for use in Dermatologic and General Surgical Procedures. FDA UDI

Identifiers

Catalog Number
ND_PRD00480-00 FDA UDI
Primary DI / UDI-DI
07290016814668 FDA UDI
510(k) Number
K120513 FDA UDI
FDA Product Code
GEI FDA UDI
OUH FDA UDI
GMDN Term
Multi-modality skin/body contouring system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4400 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

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Multi-modality skin/body contouring system

PURE DentA by Endymed Medical Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multi-modality skin/body contouring system.

Cleared under the same submission

K120513 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Endymed Medical Ltd

Sources (1)

  • FDA UDI b20eabaf-f2d0-4391-b210-703139f7201e 35 fields · synced May 30, 2026