FDA UDI
In Commercial Distribution
🇺🇸 United States
TPH Spectra ST
DI: D0106420161
·
Model: 642016
·
Dentsply De Trey GmbH
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- TPH Spectra ST
- Primary DI
- D0106420161
- Version / Model
- 642016
- Catalog Number
- 642016
- Company Name
- Dentsply De Trey GmbH
- Labeler DUNS
- 315471722
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2025-12-11
- Public Version
- 1
- Public Version Date
- 2025-12-19
- Public Version Status
- New
- Public Device Record Key
- 4b343f83-211d-4faa-aa97-ba0884b724f1
Device Description
TPH Spectra ST SureSmile Sample Kit is a sample kit for bonded attachments with TPH Spectra ST
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EBF | Material, tooth shade, resin | Dental | 872.3690 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35870 | Dental composite resin | A non-sterile substance intended for professional use as a dental luting agent, liner, base, pulp-capping material, pit/fissure sealant, and/or direct dental restorative material, whereby the majority of the setting reaction is based on the self-, light-, or dual-cured polymerization of a dimethacrylate resin [e.g., polymethylmethacrylate (PMMA), polyurethane, or bisphenol-A-diglycidylether methacrylate (Bis-GMA)]; it includes some additional fillers/components (e.g., glass-based, quartz, or ceramic). It may be preloaded into a syringe, and dedicated disposable devices associated with application may be included. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | D0106420160 | HIBCC | ||||
| Primary | D0106420161 | HIBCC |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | 0.25 | Gram | |
| Device Size Text, specify | Paste |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep out of direct sunlight and protect from moisture