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SureSmile®

FDA UDI

Class I (US FDA UDI)

by Dentsply Sirona Orthodontics Inc.

Identity

Trade Name
SureSmile® FDA UDI
Generic Name
Interproximal reduction kit FDA UDI
Device Name
SureSmile Aligner Starter Kit (Doctor Kit) FDA UDI
Model / Reference
ORX00006 FDA UDI
Description
SureSmile Aligner Starter Kit (Doctor Kit) FDA UDI

Identifiers

Catalog Number
ORX00006 FDA UDI
Primary DI / UDI-DI
D746ORX000061 FDA UDI
FDA Product Code
EHM FDA UDI
GMDN Term
Interproximal reduction kit FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.6010 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

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

Category: Interproximal reduction kit

SureSmile® by Dentsply Sirona Orthodontics Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Interproximal reduction kit.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Dentsply Sirona Orthodontics Inc.

Sources (1)

  • FDA UDI 04c439e3-b78c-4731-92a4-6d479c72c089 35 fields · synced Jun 9, 2026