Screw retained type Abutment

FDA UDI

Class II (US FDA UDI)

by InnoBioSurg Co., Ltd(IBS implant Co., Ltd)

Identity

Trade Name: Screw retained type Abutment FDA UDI
Generic Name: Dental implant system FDA UDI
Model / Reference: SAH4501 FDA UDI

Identifiers

Primary DI / UDI-DI: 08800039321792 FDA UDI
510(k) Number: K153350 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

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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Dental implant system

Screw retained type Abutment by InnoBioSurg Co., Ltd(IBS implant Co., Ltd) — 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
Implant Regular — BIO CONCEPT Co., Ltd. · Class II
TRI — Tri Dental Implants Int. AG · Class II
Denture Retention Attachments — IMPLANT ATTACHMENTS LLC · Class II
Chaorum Implant System — Medimecca Co., Ltd. · Class II
JDEvolution Plus — Jdentalcare Srl · Class II

Cleared under the same submission

K153350 also covers:

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: InnoBioSurg Co., Ltd(IBS implant Co., Ltd)

Sources (1)

FDA UDI 3b19d2f3-4407-4ebf-986d-bd4a26af3d72 33 fields · synced May 31, 2026