Primeprint Guide 2 04752
by DETAX GmbH
Primeprint Guide 2 04752 is a Class I device made by DETAX GmbH, listed in FDA GUDID since 1 Sep 2026 (UDI-DI EDET047521), registry data as of 23 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | NumberEDET047521 | Date1 Sep 2026 | StatusListed |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Primeprint Guide 2
- Generic name
- Removable dental occlusal splint, custom-made
- Model / reference
- 04752
- Primary DI / UDI-DI
- EDET047521
- FDA product code
- KMY, DYJ, DYT, NDP
- GMDN term
- Removable dental occlusal splint, custom-made
- Device class
- Class I
- Regulation number
- 872.5525, 872.5410, 872.3980
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code KMY (Positioner, Tooth, Preformed).
- Proform 9614960R2 by Keystone Industries
- Proform 9640961 by Keystone Industries
- PERFORMED TEMPLATE W/FRAGRANCE FOR TOOTH POSTIONER by American Orthodontics
- RELAX-O-GUARD by Aquatemp Service Co., Inc.
- AQUALIZER MOUTHPIECE by Martin D. Lerman
- DYNAMIC FUNTIONAL POSITIONER by Dynamic Functional Positioner, Inc.
- DENT-O-CRYL ORTHODONTIC ACRYLIC by Dentauraum, Inc.
- PREFORMED TOOTH POSITIONER by Tp Laboratories, Inc.
- REMOLDABLE CRANIOMANDIBULAR APPLIANCE by Jeffrey H. Attlin
- NITE-GUIDE by Ortho-Tain, Inc