Salvin Dental Specialties

Basic Information

• Brand Name: Salvin Dental Specialties
• Primary DI: 00841336108646
• Version / Model: IMPLA-SAFE-CEM-REMOVER
• Catalog Number: IMPLA-SAFE-CEM-REMOVER
• Company Name: SALVIN DENTAL SPECIALTIES, LLC
• Labeler DUNS: 113344790
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-11-11
• Public Version: 1
• Public Version Date: 2025-11-19
• Public Version Status: New
• Public Device Record Key: 53c93851-7c6d-40ff-a0b9-27b3f7a11553

Device Description

ImplaSafe Cement Remover - Titanium Tip

Device Characteristics

• Single Use: No
• 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: Yes
• 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
EIS	REMOVER, CROWN	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
59273	Alagille syndrome IVD, kit, nucleic acid technique (NAT)	A collection of reagents and other associated materials intended to be used to evaluate a clinical specimen to diagnose, monitor or predict the inborn genetic condition Alagille syndrome, associated with mutations in the JAG1 or NOTCH2 gene, using a nucleic acid technique (NAT).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00841336108646	GS1