CORNERSTONE BIOCOMP ENTERPRISES INC

FDA Device Registration & Listing · Bristol, PA, US · Registration 3005126636

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3005126636
FEI Number
3005126636
Entity Name
CORNERSTONE BIOCOMP ENTERPRISES INC
City/State/Country
Bristol, PA, US
Establishment Address
100 Wood St, Bristol, PA 19007, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
CORNERSTONE BIOCOMP ENTERPRISES INC (Owner Number: 9068699)
Owner / Operator Contact Address
100 Wood Street, Bristol, PA 19007, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Temp Crown Retainer All ceramic crown Full Denture Abutment, implant, dental, endosseous - Neoss Abutment Partial Denture Inlay onlay All case SP Crown Abutment, implant, dental, endosseous - Preat Abutment Abutment, implant, dental, endosseous - Keystone Abutment

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NSN Restoration, Resin, Crown And Bridge Unknown Class N N/A 2012-11-01
NSR Prosthesis, Orthodontic Unknown Class N N/A 2012-11-01
NSP Restoration, Porcelain Unknown Class N N/A 2012-11-01
NSL Dentures, Full Unknown Class N N/A 2012-11-01
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2023-12-18
NSK Dentures, Partial Unknown Class N N/A 2012-11-01
NSM Restoration, Resin Unknown Class N N/A 2012-11-01
NSJ Restoration, Noble Metal Unknown Class N N/A 2012-11-01
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2023-03-27
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2023-12-18

Official Correspondent

Jay Collins

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

CORNERSTONE BIOCOMP ENTERPRISES 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
K211871 Faico Medical, LLC FAICO Dental Implant System and CAD/CAM Abutments 2021-11-18

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0007-2018 Implant Direct Sybron Manufacturing, LLC 2
Implant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm, Rx only, Sterile Dental Implant component.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005126636. Last updated year: 2026. Please use registration number 3005126636 when referencing this establishment in official correspondence.
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