O-Ring Purple Xtra Strong for 2.2mm Ball (10 Pack)

FDA UDI

Class I (US FDA UDI)

by Sterngold Dental LLC

Identity

Trade Name: O-Ring Purple Xtra Strong for 2.2mm Ball (10 Pack) FDA UDI
Generic Name: Resilient dental precision attachment FDA UDI
Device Name: O-rings provide retention, sealing, and comfort for overdentures. Made from biocompatible material, they ensure safety and compatibility with oral tissues while preventing debris and bacteria from entering the implant-abutment interface. FDA UDI
Model / Reference: 909018 FDA UDI
Description: O-rings provide retention, sealing, and comfort for overdentures. Made from biocompatible material, they ensure safety and compatibility with oral tissues while preventing debris and bacteria from entering the implant-abutment interface. FDA UDI

Identifiers

Primary DI / UDI-DI: 00841549119156 FDA UDI
FDA Product Code: NDP FDA UDI
GMDN Term: Resilient dental precision attachment FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.3980 FDA UDI
Commercial Distribution: 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

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

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

Category: Resilient dental precision attachment

O-Ring Purple Xtra Strong for 2.2mm Ball (10 Pack) by Sterngold Dental LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 c6a986f7-fa47-487a-9082-32bc8048d772 34 fields · synced Jun 8, 2026