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Pekkton ivory

FDA UDI

Class II (US FDA UDI)

by Cendres+Métaux SA

Identity

Trade Name
Pekkton ivory FDA UDI
Generic Name
Dental appliance fabrication material, thermoplastic FDA UDI
Device Name
Pekkton® ivory milling blank ø 98.5/16mm (with steps) FDA UDI
Model / Reference
01060011 FDA UDI
Description
Pekkton® ivory milling blank ø 98.5/16mm (with steps) FDA UDI

Identifiers

Catalog Number
01060011 FDA UDI
Primary DI / UDI-DI
07640166511458 FDA UDI
510(k) Number
K170102 FDA UDI
FDA Product Code
EBF FDA UDI
GMDN Term
Dental appliance fabrication material, thermoplastic FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.3690 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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Dental appliance fabrication material, thermoplastic

Pekkton ivory by Cendres+Métaux SA — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental appliance fabrication material, thermoplastic.

Cleared under the same submission

K170102 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Cendres+Métaux SA

Sources (1)

  • FDA UDI a7bccef3-98d1-4b19-93ee-22872795ba20 38 fields · synced Jun 6, 2026