DD medical polymers
510(k) K153490
DD medical polymers is a Class II device made by Dental Direkt GmbH, cleared under FDA 510(k) K153490 on 13 May 2016, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK153490 | Date13 May 2016 | StatusActive |
Official records
- FDA 510(k) database K153490
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- EBG
- Device class
- Class II
- Regulation
- 21 CFR Part 872.3770
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
Similar devices
Other devices filed under FDA product code EBG (Crown And Bridge, Temporary, Resin).
- G-CAM GC00314 by GRAPHENANO DENTAL SL.
- Aidite PMMA by Aidite (Qinhuangdao) Technology Co., Ltd.
- G-CAM GC00235 by GRAPHENANO DENTAL SL.
- PRELUDE (TEMPORARY CROWN AND BRIDGE CEMENT) by SCIENTIFIC PHARMACEUTICALS, INC.
- IDODENTINE DISC A3 MULTI 98,5/16mm 4516/A3 by UNION DENTAL SA
- ANAXDENT PMMA U MULTIBLANK B0 98,5/16mm 18120216 by UNION DENTAL SA
- TempFIT Temporary Crown and Bridge Resin by Rizhao HuGe Biomaterials Company, Ltd.
- BELLEGLASHP by Sybron Dental Specialties, Inc.
- PROTEMP H by Espe Dental AG
- Fixtemp C&B by Dreve Dentamid GmbH