Sds1.2

FDA UDI

Class II (US FDA UDI)

by SDS Swiss Dental Solutions AG

Identity

Trade Name: SDS1.2 FDA UDI
Generic Name: Dental implant system FDA UDI
Device Name: SDS1.2 healing cap-disc 9x12 FDA UDI
Model / Reference: SDS1.2_HC-disc-9x12 FDA UDI
Description: SDS1.2 healing cap-disc 9x12 FDA UDI

Identifiers

Primary DI / UDI-DI: 04260468255374 FDA UDI
FDA Product Code: NHA FDA UDI
GMDN Term: Dental implant 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

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Dental implant system

Sds1.2 by SDS Swiss Dental Solutions AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental implant system.

Healing abutment Regular — BIO CONCEPT Co., Ltd. · Class II
Ball Attachment 5 mm — NOGA MEDICAL PRODUCTS LTD · Class II
Equator Abutment, Φ 6.5mm, GH 2mm — BIO CONCEPT Co., Ltd. · Class II
Short Abutment — InnoBioSurg Co., Ltd(IBS implant Co., Ltd) · Class II
Magicore — InnoBioSurg Co., Ltd(IBS implant Co., Ltd) · Class II
Magicore S — InnoBioSurg Co., Ltd(IBS implant Co., Ltd) · Class II
Implant Regular — BIO CONCEPT Co., Ltd. · Class II
TRI — Tri Dental Implants Int. AG · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: SDS Swiss Dental Solutions AG

Sources (1)

FDA UDI 51793562-1fa6-47b1-8f6c-e68081d66bd0 34 fields · synced May 31, 2026