Stern EX Surgical Kit Complete

FDA UDI

Class II (US FDA UDI)

by Sterngold Dental LLC

Identity

Trade Name: Stern EX Surgical Kit Complete FDA UDI
Generic Name: Dental/maxillofacial surgical procedure kit, medicated, reusable FDA UDI
Device Name: The Stern IC Surgical Kit consists of various surgical tools such as drills, countersinks, bone taps, insertion tools and torque wrenches. Intended to be used during implant surgical procedure to drill, bone tap or countersink bone or tissue in the mandible or maxilla of patient. It consists of surgical tools needed for the implant surgical procedure. FDA UDI
Model / Reference: 905129 FDA UDI
Description: The Stern IC Surgical Kit consists of various surgical tools such as drills, countersinks, bone taps, insertion tools and torque wrenches. Intended to be used during implant surgical procedure to drill, bone tap or countersink bone or tissue in the mandible or maxilla of patient. It consists of surgical tools needed for the implant surgical procedure. FDA UDI

Identifiers

Primary DI / UDI-DI: 00841549114533 FDA UDI
510(k) Number: K111798 FDA UDI
FDA Product Code: DZI FDA UDI
GMDN Term: Dental/maxillofacial surgical procedure kit, medicated, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.4120 FDA UDI
Commercial Distribution: Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

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

Yes

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Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Stern EX Surgical Kit Complete by Sterngold Dental LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K111798 also covers:

Stern IC RN Solid Abutment 4.0mm — Sterngold Dental LLC

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: Sterngold Dental LLC

Sources (1)

FDA UDI ad4cf0c4-e69e-495d-a6a1-0f565dc3a755 36 fields · synced Jun 8, 2026