Silicone Dam 10PK

Basic Information

• Brand Name: Silicone Dam 10PK
• Primary DI: D990SD10PK0
• Version / Model: SD10PK
• Company Name: SMART DENTURE CONVERSIONS, LLC
• Labeler DUNS: 010613514
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-05-19
• Public Version: 2
• Public Version Date: 2025-06-11
• Public Version Status: Update
• Public Device Record Key: 48676e65-46d1-4277-94f8-01b34ef2229d

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EIE	Dam, Rubber	Dental	872.6300	1

GMDN Terms

Code	Name	Definition	Implantable	Status
45004	Rubber dam, non-latex	A sheet of elastomeric synthetic material (e.g., silicone) that is punched with holes and placed over the teeth during dental procedures. It can have a variety of functions such as: 1) to isolate the field of operation from the rest of the oral cavity; 2) to eliminate saliva; 3) to prevent the patient swallowing liquid/dental material; 4) to protect soft tissue from harmful solutions; and 5) to reduce risk of infection. This device may be used for patients and/or staff that have an allergy to latex. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D990SD10PK0	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]