Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009582362

FEI Number

3009582362

Entity Name

OXFORD PERFORMANCE MATERIALS, INC.

City/State/Country

South Windsor, CT, US

Establishment Address

30 South Satellite Road, South Windsor, CT 06074, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

Oxford Performance Materials, Inc. (Owner Number: 10043473)

Owner / Operator Contact Address

30 South Satellite Road, South Windsor, CT 06074, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K121818

PMA Number

N/A

All Registered Proprietary Names

Pekkton® Ivory Milling blank 98.5/t24mm Pekkton® Ivory Milling blank 95/t25mm Pekkton® Ivory Milling blank 98.5/t28mm Pekkton® Ivory Milling blank 98.5/t16mm Pekkton® Ivory Milling blank 98.5/t12mm Pekkton® Ivory Milling blank 98.5/t20mm Pekkton® Ivory Milling blank 95/t16mm Pekkton® Ivory Milling blank 95/t20mm Pekkton® Ivory Milling blank 95/t12mm Pekkton® Ivory Milling blank 95/t30mm HTR-PEKK OsteoFab Patient Specific Facial Device - Optimized HTR-PEKK OsteoFab Patient Specific Cranial Device

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JCT	Prosthesis, Tracheal, Expandable	General, Plastic Surgery	Class 2	878.3720	2017-08-01
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2020-09-10
KKY	Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction	General, Plastic Surgery	Class 2	878.3500	2016-08-19
GXN	Plate, Cranioplasty, Preformed, Non-Alterable	Neurology	Class 2	882.5330	2013-02-20

Official Correspondent

James Porteus

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Oxford Performance Materials, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K952662	Jeneric/Pentron, Inc.	COMP=FLOW	1995-08-28
K171147	Bisco, Inc.	REVEAL Bulk	2017-08-04
K770922	Espe GmbH (Us)	DENTAL RESTORATIVE IN CAPSULES	1977-06-01
K153476	Kuraray Noritake Dental, Inc.	KATANA AVENCIA Block	2016-08-23
K080507	Ceremed , Inc.	AOC POROUS POLYETHYLENE, AOC POROUS HDPE, AOC POROUS POLYETHYLENE SURGICAL IMPLANT	2008-04-21

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0028-2020	Voco GmbH Anton-Flettner-Str. 1-3 Cuxhaven Germany	2	Grandio SO Heavy Flow Caps, Color A3 - Product Usage: Filling minimally invasive cavities of all classes - Filling small class I cavities and extended fissure sealing - Filling class II - V cavities including V-shaped defects and cervical caries - Blocking out undercuts - Lining or coating cavities - Repairing fillings and veneers - Luting translucent prosthetic pieces (e.g., full ceramic crowns, etc.).

Similar Registrations

Registration Number	Establishment Name	Location
3006950086	Merit Medical Nederland BV	Maastricht Airport Limburg, NL
1123137	STERILIZATION SERVICES OF VIRGINIA	RICHMOND, VA, US
3012536737	Merit Medical Canada Ltd.	Markham Ontario, CA
1721676	Sterigenics U.S., LLC	Salt Lake City, UT, US
1724474	Terumo BCT STERILIZATION SERVICES, Inc.	LAKEWOOD, CO, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009582362. Last updated year: 2026. Please use registration number 3009582362 when referencing this establishment in official correspondence.