← Back to catalogue

ORA Retaining Cap

FDA UDI

Class I (US FDA UDI)

by Sterngold Dental LLC

Identity

Trade Name
ORA Retaining Cap FDA UDI
Generic Name
Resilient dental precision attachment FDA UDI
Device Name
The retaining cap engages the outside of the ball shape and allows retention of the prosthesis to the denture. FDA UDI
Model / Reference
904064 FDA UDI
Description
The retaining cap engages the outside of the ball shape and allows retention of the prosthesis to the denture. FDA UDI

Identifiers

Primary DI / UDI-DI
00841549115776 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
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Resilient dental precision attachment

ORA Retaining Cap by Sterngold Dental LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Resilient dental precision attachment.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Sterngold Dental LLC

Sources (1)

  • FDA UDI 1bdfab75-409b-4450-a7d0-20c9a3d8eace 34 fields · synced May 30, 2026