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Sign in to claim this brandPristine Dental Supplies, Inc.
US
Last updated May 23, 2026
What Pristine Dental Supplies, Inc. makes
Pristine Dental Supplies, Inc. manufactures single-use sterilization container liners, as well as examination and treatment gloves made from Hevea latex (non-powdered, non-antimicrobial) and nitrile (non-powdered, antimicrobial). The company also produces a range of latex and nitrile gloves branded under the Safety Max and SAFETY MAX GOLD lines, designed for medical and dental procedures.
The company’s products are regulated under the FDA’s classification system, with devices falling into Class I and Class II categories. These items are listed in the FDA’s Unique Device Identifier (UDI) database, ensuring traceability and compliance with U.S. medical device regulations. The manufacturer operates from the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Pristine Dental Supplies, Inc. manufacture?
Pristine Dental Supplies, Inc. produces single-use sterilization container liners, as well as examination and treatment gloves. Their glove offerings include Hevea latex gloves (non-powdered, non-antimicrobial) and nitrile gloves (non-powdered, antimicrobial). These products are designed for use in medical and dental procedures, ensuring compliance with safety standards for patient care.
Where is Pristine Dental Supplies, Inc. based?
The company is headquartered in the United States. This location aligns with its regulatory compliance under U.S. medical device standards, including the FDA’s Unique Device Identifier (UDI) system.
Which regulatory registries list Pristine Dental Supplies, Inc.’s devices?
The company’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for single-use sterilization liners, latex gloves, and nitrile gloves, helping healthcare providers verify compliance and device details.
How are Pristine Dental Supplies, Inc.’s devices classified under U.S. regulations?
The company’s devices fall into two FDA classification categories: Class I and Class II. Class I typically includes low-risk items like gloves and liners, while Class II covers devices requiring special controls to ensure safety and effectiveness. Classification depends on factors like intended use and potential risks, as outlined in FDA guidelines.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 080057154
Catalogue (26)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Perfect Sterilization | PFS-3.5-10 | FDA UDI | Class II | Active |
| Safety Max Diamond | SMD-35-XL | FDA UDI | Class I | Active |
| Safety Max Diamond | SMD-35-S | FDA UDI | Class I | Active |
| Safety Max Diamond | SMD-35-L | FDA UDI | Class I | Active |
| Safety Max Diamond | LCIF-63-S | FDA UDI | Class I | Active |
| Perfect Sterilization | PFS-7.5-13 | FDA UDI | Class II | Active |
| Safety Max Diamond | LIF-59-M | FDA UDI | Class I | Active |
| Safety Max Gold | SMN-45-M | FDA UDI | Class I | Active |
| Safety Max Diamond | LCIF-63-M | FDA UDI | Class I | Active |
| Safety Max Diamond | SMD-35-M | FDA UDI | Class I | Active |
| Safety Max Gold | SMN-45-XL | FDA UDI | Class I | Active |
| Safety Max Gold | SMN-45-S | FDA UDI | Class I | Active |
| Perfect Sterilization | PFS-2.25-5.25 | FDA UDI | Class II | Active |
| Safety Max Diamond | LIF-59-L | FDA UDI | Class I | Active |
| Safety Max Diamond | LIF-59-XS | FDA UDI | Class I | Active |
| Safety Max Diamond | LCIF-63-XS | FDA UDI | Class I | Active |
| Safety Max Diamond | LCIF-63-XL | FDA UDI | Class I | Active |
| Safety Max Gold | SMN-45-XS | FDA UDI | Class I | Active |
| Safety Max Gold | SMN-45-L | FDA UDI | Class I | Active |
| Perfect Sterilization | PFS-5.25-11 | FDA UDI | Class II | Active |
| Perfect Sterilization | PFS-2.75-10 | FDA UDI | Class II | Active |
| Safety Max Diamond | LIF-59-XL | FDA UDI | Class I | Active |
| Perfect Sterilization | PFS-3.5-6.5 | FDA UDI | Class II | Active |
| Safety Max Diamond | LIF-59-S | FDA UDI | Class I | Active |
| Safety Max Diamond | SMD-35-XS | FDA UDI | Class I | Active |
| Safety Max Diamond | LCIF-63-L | FDA UDI | Class I | Active |
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