Integra® Miltex®

FDA UDI

Class II (US FDA UDI)

by Integra LifeSciences Production Corporation

Identity

Trade Name: Integra® Miltex® FDA UDI
Generic Name: Dental anaesthesia syringe, intraligamentary FDA UDI
Device Name: N-Tralig® Intraligamentary Syringe Barrel Cap FDA UDI
Model / Reference: PN4 FDA UDI
Description: N-Tralig® Intraligamentary Syringe Barrel Cap FDA UDI

Identifiers

Catalog Number: PN4 FDA UDI
Primary DI / UDI-DI: 10381780532422 FDA UDI
510(k) Number: K142414 FDA UDI
FDA Product Code: EJI FDA UDI
GMDN Term: Dental anaesthesia syringe, intraligamentary FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.6770 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

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

Dimensions & Sizes

Size: Outer Diameter — 12.5 Millimeter FDA UDI
Length — 15 Millimeter FDA UDI

Category: Dental anaesthesia syringe, intraligamentary

Integra® Miltex® by Integra LifeSciences Production Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental anaesthesia syringe, intraligamentary.

OSUNG MND — Osung Mnd Co., Ltd. · Class II
Pike Anesthetic Syringe — PRACTICON, INC. · Class I
SYRINGE-SELF-ASPIRATING — W.H. Holden, Inc. · Class I
ASPIRATING SYRINGE ASTRA TYPE — W.H. Holden, Inc. · Class I
SYRINGE-2CC-LUER-METAL HUB — W.H. Holden, Inc. · Class I
Henry Schein — HENRY SCHEIN, INC. · Class II
ASPIRATING SYRINGE C-W TYPE SS — W.H. Holden, Inc. · Class I
DOUBLE THREADED HUB — W.H. Holden, Inc. · Class I

Cleared under the same submission

K142414 also covers:

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 II	Pending data

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Manufacturer

Manufacturer: Integra LifeSciences Production Corporation

Sources (1)

FDA UDI 87c58c36-1740-4b12-8928-bf6854a2406c 38 fields · synced Jun 9, 2026