Magicore

FDA UDI

Class II (US FDA UDI)

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

Identity

Trade Name: Magicore FDA UDI
Generic Name: Dental implant system FDA UDI
Model / Reference: 452M4011 FDA UDI

Identifiers

Primary DI / UDI-DI: 08800039303668 FDA UDI
510(k) Number: K152520 FDA UDI
K201981 FDA UDI
FDA Product Code: DZE FDA UDI
GMDN Term: Dental implant system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3640 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

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

Magicore 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

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

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

Sources (1)

FDA UDI 800e4297-29e9-42ad-820a-8fe470208264 33 fields · synced Jun 1, 2026