TBL Mini Surgical Kit

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref 069476003001801FB

by BIO CONCEPT Co., Ltd.

Identity

Trade Name: Kit EUDAMED
TBL Mini Surgical Kit FDA UDI
BL Surgical cassette(Complete ) FDA UDI
BV Wide Kit FDA UDI
BV Prosthetic Kit FDA UDI
Surgical Instruments Kit(Standard) FDA UDI
BV MINI Kit FDA UDI
BV Guided Kit,BV FDA UDI
BV Standard KlT FDA UDI
BL MINI KIT FDA UDI
TL MINI KIT FDA UDI
BC Prosthetic Kit FDA UDI
BLT Surgical Kit FDA UDI
Generic Name: Dental implant system FDA UDI
Dental/maxillofacial surgical procedure kit, non-medicated, reusable FDA UDI
Device Name: Kit EUDAMED
Model / Reference: 069476003001801FB EUDAMED
156100 FDA UDI
156020 FDA UDI
356800 FDA UDI
356300 FDA UDI
356400 FDA UDI
357600 FDA UDI
357300 FDA UDI
357860 FDA UDI
156200 FDA UDI
056500 FDA UDI
056400 FDA UDI
156070 FDA UDI

Identifiers

Primary DI / UDI-DI: 06947600309000 EUDAMEDFDA UDI
06947600316374 EUDAMEDFDA UDI
06947600316329 EUDAMEDFDA UDI
06947600316336 EUDAMEDFDA UDI
06947600316589 EUDAMEDFDA UDI
06947600316596 EUDAMEDFDA UDI
06947600319948 EUDAMEDFDA UDI
06947600304388 EUDAMEDFDA UDI
06947600302094 EUDAMEDFDA UDI
06947600302087 EUDAMEDFDA UDI
06947600304333 EUDAMEDFDA UDI
06947600305439 EUDAMED
06947600316381 EUDAMED
06947600316923 EUDAMED
06947600309017 EUDAMED
06947600304364 FDA UDI
Basic UDI-DI: 069476003001801FB EUDAMED
510(k) Number: K212364 FDA UDI
K150388 FDA UDI
K192274 FDA UDI
FDA Product Code: NHA FDA UDI
DZE FDA UDI
NYE FDA UDI
EMDN Code: L159099 ODONTOSTOMATOLOGY INSTRUMENTS, REUSABLE - OTHER EUDAMED
GMDN Term: Dental implant system FDA UDI
Dental/maxillofacial surgical procedure kit, non-medicated, reusable FDA UDI

Classification

Device Class: Class IIa EUDAMED
Class II FDA UDI
Class I FDA UDI
Regulation Number: 872.3630 FDA UDI
872.3640 FDA UDI
872.3980 FDA UDI
Medical Purpose: The devices are intended to be used for planning, placement, maintenance and explantation of the implants from BIOCONCEPT Dental Implant System. EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

FDA UDIFDA UDI

Implantable

Yes

FDA UDIFDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDIFDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDIFDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDIFDA UDI

Lot / Batch Number

Yes

FDA UDIFDA UDI

Serial Number

FDA UDIFDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Dental implant system

TBL Mini Surgical Kit by BIO CONCEPT Co., Ltd. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Dental implant system.

Ball Attachment 5 mm — NOGA MEDICAL PRODUCTS 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
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 (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDR	—	Class II	Unknown
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: BIO CONCEPT Co., Ltd.

Sources (27)

FDA UDI 2bda200f-48d0-4c61-83d8-136b753ca335 33 fields · synced Sep 18, 2026
FDA UDI 4e6c68ce-29a3-45d2-9dcc-b1c35c725a5d 33 fields · synced May 29, 2026
FDA UDI 38f61a7d-03d3-41b0-ac04-ecef2723b54f 33 fields · synced May 30, 2026
FDA UDI a9a85f9f-2a24-4d87-97fe-0cb4f0794095 33 fields · synced May 30, 2026
FDA UDI d33ad200-dfdb-45ba-a859-9a4973543edd 33 fields · synced May 30, 2026
FDA UDI 6841e3ec-5d2b-4c9b-b8fa-805a8db026ff 32 fields · synced May 30, 2026
FDA UDI 8331fd8b-be43-4842-a396-a3cba40e9652 32 fields · synced May 30, 2026
FDA UDI 4b463bac-10d0-4c10-8321-cfdb0ce4dcc3 32 fields · synced May 30, 2026
FDA UDI 37e63dca-1c1a-417b-9db7-4680c9ee3afa 32 fields · synced May 30, 2026
FDA UDI 88cac8fe-f316-4d6c-bf39-98e479687ffd 32 fields · synced May 30, 2026
FDA UDI 5aa13be6-d2e2-4118-bc12-1661ae54b366 33 fields · synced May 30, 2026
FDA UDI 9a60db59-88f9-4191-91c8-e897a1577c08 33 fields · synced May 30, 2026
EUDAMED 9ace14b3-3937-4c6a-84fc-a91424e1b9c0 61 fields · synced Jun 20, 2026
EUDAMED 4a121aa0-7984-478b-a87c-9a6f617ceffc 61 fields · synced Jul 9, 2026
EUDAMED cec471ae-70f1-4546-b441-8393f278e844 61 fields · synced Jul 9, 2026
EUDAMED 0aeff29b-000a-41fc-93ae-28bf8740e869 61 fields · synced Jul 9, 2026
EUDAMED 7c42bcdc-56f4-4028-addd-30692ee8fed0 61 fields · synced Jul 10, 2026
EUDAMED 738d77dc-bc12-498b-b73d-66a84af97ed3 61 fields · synced Jul 11, 2026
EUDAMED 5c116040-efa7-4f7b-b7ef-9af4b30ab27f 61 fields · synced Jul 15, 2026
EUDAMED 917661be-42f7-49b5-b1f5-c6b64d08b93b 61 fields · synced Jul 16, 2026
EUDAMED a783831f-aeeb-45c0-9929-c2d6a89edea5 61 fields · synced Jul 17, 2026
EUDAMED 0b9d4128-dc42-4fbb-b18a-61f91e79d766 61 fields · synced Jul 18, 2026
EUDAMED bbf89ed4-b704-4f04-b369-7e2ecd564a3f 61 fields · synced Jul 21, 2026
EUDAMED 91ab839b-9021-4eb5-838a-7c223a63b08b 61 fields · synced Jul 30, 2026
EUDAMED c9e72695-ffb2-4712-8018-5e79a5e2152e 61 fields · synced Jul 31, 2026
EUDAMED 2d2a9e28-73f9-474f-a5d2-5b1e7870edf3 61 fields · synced Sep 18, 2026
EUDAMED 90333f75-3212-4dcd-b161-4b772d278374 61 fields · synced Sep 18, 2026