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Ot Equator Titanium Abutment

FDA UDI

Class II (US FDA UDI)

by Rhein 83 Srl

Identity

Trade Name
OT EQUATOR TITANIUM ABUTMENT FDA UDI
Generic Name
Spark-gap orthopaedic extracorporeal shock wave therapy system FDA UDI
Device Name
DISPOSABLE medical device to be screwed into a dental implant. The connection and the thread are compatible with the specific implant. Available in different cuff heights. FDA UDI
Model / Reference
OT EQUATOR CoAxis H/E ø 3,25 h.5 FDA UDI
Description
DISPOSABLE medical device to be screwed into a dental implant. The connection and the thread are compatible with the specific implant. Available in different cuff heights. FDA UDI

Identifiers

Catalog Number
030COA35 FDA UDI
Primary DI / UDI-DI
08059224183534 FDA UDI
FDA Product Code
NHA FDA UDI
GMDN Term
Spark-gap orthopaedic extracorporeal shock wave therapy system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.3630 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

No

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: Spark-gap orthopaedic extracorporeal shock wave therapy system

Ot Equator Titanium Abutment by Rhein 83 Srl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Spark-gap orthopaedic extracorporeal shock wave therapy system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Rhein 83 Srl

Sources (1)

  • FDA UDI 4bdbce11-1aa9-4974-b6a1-2ef2b1459e02 34 fields · synced Jun 8, 2026