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GuidedSMILE

FDA UDI

Class I (US FDA UDI)

by Guided Smile

Identity

Trade Name
GuidedSMILE FDA UDI
Generic Name
Fixture/appliance dental drill bit, reusable FDA UDI
Device Name
Fixation Kit - Short & Long FDA UDI
Model / Reference
FIX03 FDA UDI
Description
Fixation Kit - Short & Long FDA UDI

Identifiers

Primary DI / UDI-DI
00850065193076 FDA UDI
FDA Product Code
NDP FDA UDI
GMDN Term
Fixture/appliance dental drill bit, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.3980 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Fixture/appliance dental drill bit, reusableDental implantation drilling template retention pin

GuidedSMILE by Guided Smile — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental implantation drilling template retention pin.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Guided Smile

Sources (1)

  • FDA UDI a28cf624-d19f-4bf2-9b48-8337498e18af 33 fields · synced Jun 8, 2026