ERA Implant® Surgical Kit, Complete

FDA UDI

Class II (US FDA UDI)

by Sterngold Dental LLC

Identity

Trade Name: ERA Implant® Surgical Kit, Complete FDA UDI
Generic Name: Dental/maxillofacial surgical procedure kit, medicated, reusable FDA UDI
Device Name: The ERA Implant 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: 905119 FDA UDI
Description: The ERA Implant 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: 00841549114526 FDA UDI
510(k) Number: K041271 FDA UDI
FDA Product Code: DZE FDA UDI
GMDN Term: Dental/maxillofacial surgical procedure kit, medicated, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3640 FDA UDI
Commercial Distribution: Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

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Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

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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

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Serial Number

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Expiration Date

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Manufacturing Date

Yes

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Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

ERA Implant® Surgical Kit, Complete by Sterngold Dental LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K041271 also covers:

ERA Implant® 3.25 Countersink Drill 13mm, Micro — 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 8e349f9e-346d-4a53-bb80-6797645be789 36 fields · synced Jun 8, 2026