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Standard Plus Implant

FDA UDI

Class II (US FDA UDI)

by BIO CONCEPT Co., Ltd.

Identity

Trade Name
Standard Plus Implant FDA UDI
Generic Name
Dental implant system FDA UDI
Model / Reference
011010 FDA UDI

Identifiers

Primary DI / UDI-DI
06947600300007 FDA UDI
510(k) Number
K150388 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
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

Yes

FDA UDI

Prescription Use

No

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
MRI Safety
MR Safe FDA UDI

Standard Plus Implant by BIO CONCEPT Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K150388 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
BIO CONCEPT Co., Ltd.

Sources (1)

  • FDA UDI 18e0e270-dc3e-4991-9196-bf97e847f794 34 fields · synced Jun 8, 2026