ERA® Direct Overdenture Mixed Kit SS

FDA UDI

Class I (US FDA UDI)

by Sterngold Dental LLC

Identity

Trade Name: ERA® Direct Overdenture Mixed Kit SS FDA UDI
Generic Name: Resilient dental precision attachment FDA UDI
Device Name: This part contains: Small diameter post females, 2-0° plus one each 5°, 11°, and 17°, Large diameter post females, 2-0° plus one each 5°, 11°, and 17°, Males, 10 sets of 5 - 2 ea of white, black and 1 orange, 2 metal jackets, 2 sets of 4, Processing jigs, 4, Alignment handles, 4, Pilot drills, 2 blockout spacers, 1 small diameter and 1 large diameter, Countersink burs, 1 small diameter and 1 large diameter, Gutta percha drill, core cutter bur and seating tool. These attachments are placed in the retained tooth root, which has been prepared to receive the fixed attachment component. The other component of the attachment becomes part of a patient removable overdenture, which is a denture partially supported by one or more retained roots. ERA Direct Placement Overdenture is available in standard and micro sizes. An optional metal jacket is also available to hold the attachment male in the denture base and is sold pre-loaded with a black fabrication male. Intended to support and/or retain removable dental prostheses in the treatment of partially or totally edentulous patients to restore chewing function. FDA UDI
Model / Reference: 811398 FDA UDI
Description: This part contains: Small diameter post females, 2-0° plus one each 5°, 11°, and 17°, Large diameter post females, 2-0° plus one each 5°, 11°, and 17°, Males, 10 sets of 5 - 2 ea of white, black and 1 orange, 2 metal jackets, 2 sets of 4, Processing jigs, 4, Alignment handles, 4, Pilot drills, 2 blockout spacers, 1 small diameter and 1 large diameter, Countersink burs, 1 small diameter and 1 large diameter, Gutta percha drill, core cutter bur and seating tool. These attachments are placed in the retained tooth root, which has been prepared to receive the fixed attachment component. The other component of the attachment becomes part of a patient removable overdenture, which is a denture partially supported by one or more retained roots. ERA Direct Placement Overdenture is available in standard and micro sizes. An optional metal jacket is also available to hold the attachment male in the denture base and is sold pre-loaded with a black fabrication male. Intended to support and/or retain removable dental prostheses in the treatment of partially or totally edentulous patients to restore chewing function. FDA UDI

Identifiers

Primary DI / UDI-DI: 00841549101731 FDA UDI
FDA Product Code: EGG FDA UDI
GMDN Term: Resilient dental precision attachment FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.3165 FDA UDI
Commercial Distribution: Not 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

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

ERA® Direct Overdenture Mixed Kit SS by Sterngold Dental LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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: Sterngold Dental LLC

Sources (1)

FDA UDI a1b3308b-18ff-4621-9667-f068d27e7254 35 fields · synced May 30, 2026