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ERA® Angle Gauge 0° Etched

FDA UDI

Class I (US FDA UDI)

by Sterngold Dental LLC

Identity

Trade Name
ERA® Angle Gauge 0° Etched FDA UDI
Generic Name
Dental implantation depth/angle gauge, reusable FDA UDI
Device Name
Used to choose the ERA® Implant Abutments which best accommodate your case's planned path of insertion. Made from Titanium. FDA UDI
Model / Reference
811186 FDA UDI
Description
Used to choose the ERA® Implant Abutments which best accommodate your case's planned path of insertion. Made from Titanium. FDA UDI

Identifiers

Primary DI / UDI-DI
00841549116162 FDA UDI
FDA Product Code
NDP FDA UDI
GMDN Term
Dental implantation depth/angle gauge, reusable 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

No

FDA UDI

Single Use

No

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: Dental implantation depth/angle gauge, reusable

ERA® Angle Gauge 0° Etched by Sterngold Dental LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental implantation depth/angle gauge, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Sterngold Dental LLC

Sources (1)

  • FDA UDI decd63c1-aeea-4a59-b978-50ba2fa08d76 34 fields · synced Jun 8, 2026