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Atlantis™

FDA UDI

Class II (US FDA UDI)

by Dentsply Ih, Inc.

Identity

Trade Name
ATLANTIS™ FDA UDI
Generic Name
Transgingival implant FDA UDI
Device Name
ATLANTIS Crown Abutm Ti Dup FDA UDI
Model / Reference
35404 FDA UDI
Description
ATLANTIS Crown Abutm Ti Dup FDA UDI

Identifiers

Primary DI / UDI-DI
07392532177194 FDA UDI
FDA Product Code
NHA FDA UDI
GMDN Term
Transgingival implant 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: Transgingival implant

Atlantis™ by Dentsply Ih, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Transgingival implant.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Dentsply Ih, Inc.

Sources (1)

  • FDA UDI e38da556-c35e-41f6-8a79-e63e0f1311c3 35 fields · synced May 29, 2026