Protector Needle Sheath Prop
510(k) K052725
Active
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK052725 | Date28 Dec 2005 | StatusActive |
Official records
- FDA 510(k) database K052725
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- FMI
- Device class
- Class II
- Regulation
- 21 CFR Part 880.5570
- Advisory committee
- General Hospital
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The ProTector Needle Sheath Prop PNS100 is a needle sheath protector designed to secure the cap of dental anesthesia needles. It is classified under product code FMI (Needle Protectors) and is intended to reduce the risk of needle-stick injuries during one-handed recapping procedures. This device adheres to sharps safety guidelines established by OSHA and the CDC, promoting safer handling in clinical settings. Its primary function is to maintain needle integrity while minimizing exposure risks during routine dental procedures.
The ProTector Needle Sheath Prop PNS100 is supplied as a disposable device in packs of 100 (100/Pk) and is autoclavable for sterilization. Each unit measures 2.5
Devices cleared under K052725
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| ProTector PNS100 | PNS100-1 / PNS100 | H816PNS1001 | — | On the market |
| ProTector PNS100 | PNS100-1 / PNS100 | H816MPNS1001 | — | On the market |
| ProTector PNS500 | PNS500-1 / PNS500 | H816PNS5001 | — | On the market |
| ProTector PNS500 | PNS500-1 / PNS500 | H816MPNS5001 | — | On the market |
Similar devices
Other devices filed under FDA product code FMI (Needle, Hypodermic, Single Lumen).
- Non-Coring Needle by Creative Care Systems, Inc.
- Needlesafe II & Needlegard II by Ingenious Technologies Corp.
- 29G And 30G K-Pack Ii Needle by Terumo Europe N.V.
- K-Pack Enhance Needle (KH-2713RBBTC and KH-2913RBBTC) by Terumo Europe N.V.
- RESHEATHER DEVICE-METAL OR PLASTIC, RESHEATER/ NEEDLE HOLDER DEVICE-PLASTIC by SAGE PRODUCTS LLC
- Unifine SafeControl by Owen Mumford Ltd
- Chemo-Port by Hdc Corp.
- PBC Needle by Nipro Med Industries by Philadelphia Biologics Center
- BD Eclipse Hypodermic Needle by Becton, Dickinson and Company
- Hypodermic Needle-Pro Edge Needle Protection Device by Smiths Medical Asd, Inc.