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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
Dental implant suprastructure, permanent, preformed 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
SPLINE DIAMETER 4 H 2 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
030SPL42 FDA UDI
Primary DI / UDI-DI
08059224083353 FDA UDI
FDA Product Code
NHA FDA UDI
GMDN Term
Dental implant suprastructure, permanent, preformed 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

Yes

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: Dental implant suprastructure, permanent, preformed

OT EQUATOR TITANIUM ABUTMENT is a pre-fabricated dental implant suprastructure designed for permanent, permanent implants that are screwed into the patient's jawbone. This durable device features a titanium alloy construct with various structural components and may be used as an abutment screw(s) on prostheses or as a separate mesostructure. The OT EQUATOR TITANIUM ABUTMENT is available in different cuff heights and is intended for use in general dentistry.

Similar devices

Also classified as Dental implant suprastructure, permanent, preformed.

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 f5f42564-998a-482e-acd3-0feec348194c 34 fields · synced Jul 9, 2026