FDA Registration Active 🇺🇸 United States

GingiBRAID+ Aluminum Potassium Sulfate Retraction Cord

Reg #: 2024312 · FEI: 2024312 · Expires 2025
Products
2
Proprietary Names
4
Establishment Types
3
Classifications
2

Registration Details

Registration Name
Kerr Corporation
Registration Number
2024312
FEI Number
2024312
Status
Active
Expiry Year
2025
Initial Importer
Yes
Address
1717 W Collins Ave
City
ORANGE
State
CA
ZIP
92867
Country
US

Regulatory Submissions

510(k) Number
K162536

Owner / Operator

Firm Name
SYBRON DENTAL SPECIALTIES, INC.
Operator Number
9029565
Address
1717 W. Collins Ave. Ca. 92867 USA, --
City
Orange
State
CA
Postal Code
92867
Country
US
Correspondent
Jennifer Evans

Products

Device Name Product Code
Material, Impression ELW
Cord, Retraction MVL

Proprietary Names

GingiBRAID+ Aluminum Potassium Sulfate Retraction Cord GingiKNIT+ Aluminum Potassium Sulfate Retraction Cord GingiBRAID+ ShortCut Aluminum Potassium Sulfate Retraction Cord UniBRAID+ Aluminum Potassium Sulfate Retraction Cord

Establishment Types

Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device