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Stern IC Acid Etched Implant 4.1mm RN, 1.8mm collar, 12mm, Ti

FDA UDI

Class II (US FDA UDI)

by Sterngold Dental LLC

Identity

Trade Name
Stern IC Acid Etched Implant 4.1mm RN, 1.8mm collar, 12mm, Ti FDA UDI
Generic Name
Dental implant suprastructure, permanent, preformed FDA UDI
Device Name
The Stern IC Dental Implant device is a root-form dental implant with a screw-type body, acid etched except for the neck of the implant, which is machined to a smooth finish. It is manufactured from pure grade 4 titanium with a flared neck, used for one-stage, transgingival or subgingival implantation. The neck and body include an internal taper and octagon. The implants are composed of grade 4 commercially pure titanium and are available in a range of lengths and diameters.The Stern IC Dental implant System is intended for long term surgical implantation in the bone of the patient’s upper or lower arch to provide immediate load or delayed load of prosthetic systems, such as artificial teeth, in order to restore the patient’s chewing function. It is also indicated for immediate loading with good primary stability and appropriate occlusal loading. FDA UDI
Model / Reference
902723 FDA UDI
Description
The Stern IC Dental Implant device is a root-form dental implant with a screw-type body, acid etched except for the neck of the implant, which is machined to a smooth finish. It is manufactured from pure grade 4 titanium with a flared neck, used for one-stage, transgingival or subgingival implantation. The neck and body include an internal taper and octagon. The implants are composed of grade 4 commercially pure titanium and are available in a range of lengths and diameters.The Stern IC Dental implant System is intended for long term surgical implantation in the bone of the patient’s upper or lower arch to provide immediate load or delayed load of prosthetic systems, such as artificial teeth, in order to restore the patient’s chewing function. It is also indicated for immediate loading with good primary stability and appropriate occlusal loading. FDA UDI

Identifiers

Primary DI / UDI-DI
00841549109935 FDA UDI
510(k) Number
K111798 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 IC Acid Etched Implant 4.1mm RN, 1.8mm collar, 12mm, Ti by Sterngold Dental LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K111798 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 46b4e563-05cf-4618-a4fa-9f17700d525a 36 fields · synced May 30, 2026