Reamer 29mm 035

FDA UDI

Class I (US FDA UDI)

by Diaswiss SA

Identity

Trade Name: Reamer 29mm 035 FDA UDI
Generic Name: Manual endodontic file/rasp, reusable FDA UDI
Device Name: Manual instrument for endodontic intraoral use FDA UDI
Model / Reference: 229029.035-0 FDA UDI
Description: Manual instrument for endodontic intraoral use FDA UDI

Identifiers

Primary DI / UDI-DI: 07630049990814 FDA UDI
FDA Product Code: EKP FDA UDI
GMDN Term: Manual endodontic file/rasp, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.4565 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Manual endodontic file/rasp, reusable

Reamer 29mm 035 by Diaswiss SA — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Manual endodontic file/rasp, reusable.

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Hand instrument K-file — TULSA DENTAL PRODUCTS LLC · Class I
Endodontic Files — CHANGZHOU SIFARY MEDICAL TECHNOLOGY CO., LTD. · Class IIa
ProFile .04 Taper Hand File — TULSA DENTAL PRODUCTS LLC · Class I
KOMET Root Canal Files — Gebr. Brasseler GmbH & Co. KG · Class I
Endodontic Files — CHANGZHOU SIFARY MEDICAL TECHNOLOGY CO., LTD. · Class IIa
SafeSiders — ESSENTIAL DENTAL SYSTEMS, INC. · Class I

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Diaswiss SA

Sources (1)

FDA UDI 5a7b5e58-3f4b-4f11-a2dc-245d7c0da1a6 33 fields · synced Jun 8, 2026