Zoll-Dental

FDA UDI

Class I (US FDA UDI)

by Zoll-Dental

Identity

Trade Name: ZOLL-DENTAL FDA UDI
Generic Name: Manual dental scaler, reusable FDA UDI
Device Name: N-135 FDA UDI
Model / Reference: S-N135 FDA UDI
Description: N-135 FDA UDI

Identifiers

Primary DI / UDI-DI: 00840105214137 FDA UDI
FDA Product Code: EMN FDA UDI
GMDN Term: Manual dental scaler, 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

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Manual dental scaler, reusable

Zoll-Dental by Zoll-Dental — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Henry Schein — HENRY SCHEIN, INC. · Class I
DHP Scaler Instruments — Dental Health Products Inc · Class I
NORDENT MANUFACTURING INC — NORDENT MANUFACTURING INC · Class I
NORDENT MANUFACTURING INC — NORDENT MANUFACTURING INC · Class I
KOHDENT — Kohler Medizintechnik GmbH & Co. KG · Class I
Pomee — POMEE CORPORATION · 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: Zoll-Dental

Sources (1)

FDA UDI cb51397b-0da9-4dae-ae12-5d910d6996d3 34 fields · synced May 30, 2026