Swissmeda Dental Planning System

FDA UDI

Class II (US FDA UDI)

by Swissmeda AG

Identity

Trade Name: Swissmeda Dental Planning System FDA UDI
Generic Name: Dental treatment application software FDA UDI
Model / Reference: 2.15.4 FDA UDI

Identifiers

Primary DI / UDI-DI: 07629999065512 FDA UDI
510(k) Number: K112251 FDA UDI
FDA Product Code: LLZ FDA UDI
GMDN Term: Dental treatment application software FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.2050 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

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

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Dental treatment application software

Swissmeda Dental Planning System by Swissmeda AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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iChiropro Surgery APP — Bien-Air Dental SA · Class I
Blue Sky Bio, LLC. — BLUE SKY BIO LLC · Class II
Blue Sky Bio, LLC. — BLUE SKY BIO LLC · Class II

Cleared under the same submission

K112251 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: Swissmeda AG

Sources (1)

FDA UDI 5be22c2b-132a-4629-a865-09f582b96b10 33 fields · synced Jun 6, 2026