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Stern EX Acid Etched Implant RP 3.75x18.0mm, Direct Delivery, Ti

FDA UDI

Class II (US FDA UDI)

by Sterngold Dental LLC

Identity

Trade Name
Stern EX Acid Etched Implant RP 3.75x18.0mm, Direct Delivery, Ti FDA UDI
Generic Name
Dental implant suprastructure, permanent, preformed FDA UDI
Device Name
The Sterngold Acid Etch Dental Implant System consists of standard, external-hex, self-tapping, doublethreaded, root-form endosseous implants that will be available is a variety of sizes to suit individual usedpatient needs. Each implant is provided with a cover screw. The implants are manufactured from pure, implant-grade titanium. The external surface of the implants (excluding the top three threads, the neck and the implant head) is lightly acid etched to remove any traces of contaminants remaining from the manufacturing process, and to achieve a slightly roughened microsurface to aid in implant osseointegration. The proposed implants are compatible with standard, regular platform (4. lmm), external-hex (antirotational) abutments such as the currently marketed Sterngold-ImplaMed, Implant Innovations, and Branemark System (Nobel Biocare). A specially-designed SternTwist internal grip insertion tool will be available as an accessory to the Acid Etch Implants. Intended for implantation into any area of the fully endentulous maxilla and mandible for the support of a removable or fixed dental prosthesis For implantation into any area of the partially endentulous maxilla and mandible for the support of a removable or fixed dental prosthesis For single tooth or multiple unit prosthesis. FDA UDI
Model / Reference
901645 FDA UDI
Description
The Sterngold Acid Etch Dental Implant System consists of standard, external-hex, self-tapping, doublethreaded, root-form endosseous implants that will be available is a variety of sizes to suit individual usedpatient needs. Each implant is provided with a cover screw. The implants are manufactured from pure, implant-grade titanium. The external surface of the implants (excluding the top three threads, the neck and the implant head) is lightly acid etched to remove any traces of contaminants remaining from the manufacturing process, and to achieve a slightly roughened microsurface to aid in implant osseointegration. The proposed implants are compatible with standard, regular platform (4. lmm), external-hex (antirotational) abutments such as the currently marketed Sterngold-ImplaMed, Implant Innovations, and Branemark System (Nobel Biocare). A specially-designed SternTwist internal grip insertion tool will be available as an accessory to the Acid Etch Implants. Intended for implantation into any area of the fully endentulous maxilla and mandible for the support of a removable or fixed dental prosthesis For implantation into any area of the partially endentulous maxilla and mandible for the support of a removable or fixed dental prosthesis For single tooth or multiple unit prosthesis. FDA UDI

Identifiers

Primary DI / UDI-DI
00841549108860 FDA UDI
510(k) Number
K023580 FDA UDI
FDA Product Code
DZE FDA UDI
GMDN Term
Dental implant suprastructure, permanent, preformed FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.3640 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Stern EX Acid Etched Implant RP 3.75x18.0mm, Direct Delivery, Ti by Sterngold Dental LLC — Class II — FDA UDI — listed in FDA GUDID

Cleared under the same submission

K023580 also covers:

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 3676b57e-a615-4d6b-9499-5522b40d786a 36 fields · synced May 30, 2026