ERA® Micro DO Small Post Countersink Bur

FDA UDI

Class II (US FDA UDI)

by Sterngold Dental LLC

Identity

Trade Name: ERA® Micro DO Small Post Countersink Bur FDA UDI
Generic Name: Steel dental bur, reusable FDA UDI
Device Name: A metal device used in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavity to facilitate the implantation of a dental fixture/appliance. There are depth marks along the length of some drills corresponding to the different size implant bodies. These marks are laser etched. Some drills are marked with the diameter in millimeters on the shank. Intended to be used to generate the bore into the bone into which an implant body or attachment is installed into. Preparation of the bony receptor site involves the sequential use of drills and drilling components. Sterngold Implamed offers two drilling configurations; Externally Cooled Twist Drills and Internally Cooled Spade Drills. Both styles are precision machined from high strength stainless steel and feature convenient depth markings and standard latch-type connectors. FDA UDI
Model / Reference: 811453 FDA UDI
Description: A metal device used in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavity to facilitate the implantation of a dental fixture/appliance. There are depth marks along the length of some drills corresponding to the different size implant bodies. These marks are laser etched. Some drills are marked with the diameter in millimeters on the shank. Intended to be used to generate the bore into the bone into which an implant body or attachment is installed into. Preparation of the bony receptor site involves the sequential use of drills and drilling components. Sterngold Implamed offers two drilling configurations; Externally Cooled Twist Drills and Internally Cooled Spade Drills. Both styles are precision machined from high strength stainless steel and feature convenient depth markings and standard latch-type connectors. FDA UDI

Identifiers

Primary DI / UDI-DI: 00841549102080 FDA UDI
510(k) Number: K902158 FDA UDI
FDA Product Code: DZE FDA UDI
GMDN Term: Steel dental bur, 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

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

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

ERA® Micro DO Small Post Countersink Bur by Sterngold Dental LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K902158 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: Sterngold Dental LLC

Sources (1)

FDA UDI 566b7eb4-82a4-4b97-a0a6-87d865094f69 36 fields · synced May 30, 2026