← Back to catalogue

TSIII BA Fixture

FDA 510(k)FDA UDIEUDAMED

Class II (US FDA 510(k))

510(k) K163088Ref BTS3M3518BRef BTS3M3008BRef BTS3S4515BRef BTS3S5511BRef BTS3S4013BRef BTS3S4511BRef BTS3M3520BRef BTS3S5506BRef BTS3S5510BRef BTS3M3511BRef BTS3S4507BRef BTS3S4015BRef BTS3S4508BRef 08800209380505Ref BTS3M3507BRef BTS3S4011BRef BTS3M3013BRef BTS3S4518BRef BTS3S5508BRef BTS3M3011BRef BTS3S4510BRef BTS3S4018B

by Osstem Implant Co., Ltd.

Identity

Trade Name
TSIII BA Implant EUDAMED
TSIII BA Fixture FDA UDI
TS BA Fixture System FDA UDI
Generic Name
Screw endosteal dental implant, two-piece FDA UDI
Device Name
BA Implant System EUDAMED
Model / Reference
BTS3S4013B EUDAMEDFDA UDI
BTS3S4510B EUDAMEDFDA UDI
BTS3S4511B EUDAMEDFDA UDI
BTS3S4508B EUDAMEDFDA UDI
BTS3S4011B EUDAMEDFDA UDI
BTS3S4507B EUDAMEDFDA UDI
BTS3M3511B EUDAMEDFDA UDI
BTS3M3518B EUDAMED
BTS3M3008B EUDAMED
BTS3S4515B EUDAMED
BTS3S5511B EUDAMED
BTS3M3520B EUDAMED
BTS3S5506B EUDAMED
BTS3S5510B EUDAMED
BTS3S4015B EUDAMED
08800209380505 EUDAMED
BTS3M3507B EUDAMED
BTS3M3013B EUDAMED
BTS3S4518B EUDAMED
BTS3S5508B EUDAMED
BTS3M3011B EUDAMED
BTS3S4018B EUDAMED
TS3M3511B FDA UDI
BTS3S4007B FDA UDI

Identifiers

Primary DI / UDI-DI
08800209380666 EUDAMEDFDA UDI
08800209380987 EUDAMEDFDA UDI
08800209380505 EUDAMEDFDA UDI
08800209381021 EUDAMEDFDA UDI
08800209380949 EUDAMEDFDA UDI
08800209380628 EUDAMEDFDA UDI
08800209380901 EUDAMEDFDA UDI
08800209380222 EUDAMEDFDA UDI
08800209380345 EUDAMED
08800209379905 EUDAMED
08800209381106 EUDAMED
08800209381908 EUDAMED
08800209380383 EUDAMED
08800209381748 EUDAMED
08800209381861 EUDAMED
08800209380703 EUDAMED
08800209380109 EUDAMED
08800209380024 EUDAMED
08800209381144 EUDAMED
08800209381823 EUDAMED
08800209379981 EUDAMED
08800209380741 EUDAMED
08800000965710 FDA UDI
Basic UDI-DI
88000406BA8J EUDAMED
510(k) Number
K163088 FDA 510(k)FDA UDI
FDA Product Code
DZE FDA 510(k)FDA UDI
EMDN Code
P01020101 DENTAL IMPLANTS EUDAMED
GMDN Term
Screw endosteal dental implant, two-piece FDA UDI

Classification

Device Class
Class IIb EUDAMED
Class II FDA 510(k)FDA UDI
Legislation / Framework
21 CFR Part 872.3640 FDA 510(k)
Regulation Number
872.3640 FDA 510(k)FDA UDI
Market of Registration
Czechia EUDAMED
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

Sutures

Yes

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

The TSIII BA Fixture is a dental implant fixture designed for use in oral and maxillofacial surgery. It serves as a stabilizing component for dental implants, ensuring proper alignment and fixation during osseointegration.

This fixture is supplied sterile and intended for single-use in clinical settings. It is classified under the product code DZE and has received FDA 510(k) clearance as substantially equivalent to a predicate device. The device is regulated under the Medical Device Regulation (MDR) and is manufactured by Osstem Implant Co., Ltd.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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

Manufacturer

Manufacturer
Osstem Implant Co., Ltd.

Sources (32)

  • FDA 510(k) K163088 24 fields · synced Sep 18, 2026
  • FDA UDI 9c6d3d21-11e7-410a-84c5-6b7b3fbe5cb3 34 fields · synced May 27, 2026
  • FDA UDI 38248699-060d-4019-aefd-e25cfaab31fd 33 fields · synced May 29, 2026
  • FDA UDI fd40c66d-9131-4255-8dce-888bb6865752 33 fields · synced May 30, 2026
  • FDA UDI e0d8beb6-1192-4b40-8da7-ba73282ed1c3 33 fields · synced May 30, 2026
  • FDA UDI 7bee06db-7412-42d1-9ebd-aab4463ce402 33 fields · synced May 30, 2026
  • FDA UDI f03f4e08-5997-402f-a10f-f3f3b3f3d372 33 fields · synced May 30, 2026
  • FDA UDI 59a8913c-ad49-4b41-8654-728ae4750d8f 33 fields · synced May 30, 2026
  • FDA UDI dcc6dc7b-5e84-4159-b297-05237158b329 33 fields · synced May 30, 2026
  • FDA UDI 2509feba-9d58-4319-bdba-76df9c08adf2 33 fields · synced May 30, 2026
  • EUDAMED 918ade91-b0ca-4aab-80ed-e30f1ddde9ba 61 fields · synced Jun 20, 2026
  • EUDAMED 90d4b3e8-dca5-42ba-a90d-03770fb445ea 61 fields · synced Jul 9, 2026
  • EUDAMED c1207d75-7f5e-466b-bc04-6e8671fb1fb5 61 fields · synced Jul 9, 2026
  • EUDAMED dd1d2ef0-727e-47aa-ad50-a34b63692766 61 fields · synced Jul 9, 2026
  • EUDAMED 25b6aff2-9ac0-4563-8646-2602ced3563e 61 fields · synced Jul 9, 2026
  • EUDAMED 5f582f6d-c479-4a44-99c4-780615669724 61 fields · synced Jul 10, 2026
  • EUDAMED e9e7f5e0-3ba4-4989-9d8f-aa5f988169dc 61 fields · synced Jul 10, 2026
  • EUDAMED 022f0ea0-3173-48b7-bb7d-06a76d0d85a7 61 fields · synced Jul 10, 2026
  • EUDAMED 87501415-74c8-4501-ad03-ec08b58fa2fb 61 fields · synced Jul 12, 2026
  • EUDAMED 6c015f95-8568-4bcd-8f22-655789a98d5d 61 fields · synced Jul 14, 2026
  • EUDAMED ea5d35c0-e3bf-4495-9bd7-6e8103a09f97 61 fields · synced Jul 16, 2026
  • EUDAMED 924d6984-6699-47f4-9956-c00038290e4c 61 fields · synced Jul 17, 2026
  • EUDAMED 37a51e15-c464-418c-994e-f5d80ec96c5e 61 fields · synced Jul 17, 2026
  • EUDAMED 03f494ba-14d0-42ba-a173-27fa71189cf8 61 fields · synced Jul 17, 2026
  • EUDAMED ce9f51f2-70e7-4617-9ef9-9c0ad7812d6b 61 fields · synced Jul 19, 2026
  • EUDAMED 8a685ce7-cb7d-4092-9f67-d45c54d90dde 61 fields · synced Jul 20, 2026
  • EUDAMED b05ec1bb-c669-49fa-8c48-f27489590f6b 61 fields · synced Jul 21, 2026
  • EUDAMED 2adfec94-37e4-4999-8f64-7b49bf210853 61 fields · synced Jul 25, 2026
  • EUDAMED 71b28706-2ff6-41da-a3eb-f907107dca6f 61 fields · synced Jul 25, 2026
  • EUDAMED ad04dcf0-6296-4e21-9000-bf3170623ab2 61 fields · synced Jul 29, 2026
  • EUDAMED 60ae2e6b-0f04-4bce-8bcb-c3da8cb2d874 61 fields · synced Jul 31, 2026
  • EUDAMED abfb74b2-fe37-449a-8c59-b0ce14d86233 61 fields · synced Sep 18, 2026