Identity
- Trade Name
- The Orthodontic Store FDA UDI
- Generic Name
- Dental impression material adhesive FDA UDI
- Device Name
- Bosworth Tray Adhesive FDA UDI
- Model / Reference
- 946-990 FDA UDI
- Description
- Bosworth Tray Adhesive FDA UDI
Identifiers
- Catalog Number
- 946-990 FDA UDI
- Primary DI / UDI-DI
- 00840326406915 FDA UDI
- 510(k) Number
- K102836 FDA UDI
- FDA Product Code
- ELW FDA UDI
- GMDN Term
- Dental impression material adhesive FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3660 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dental impression material adhesive
The Orthodontic Store by Young Innovations, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental impression material adhesive.
- Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLC · Class I
- 3M™ — 3M Deutschland GmbH · Class I
- Affinity™ Tray Adhesive — CLINICIAN'S CHOICE DENTAL PRODUCTS, INC. · Class I
- 3M™ Impregum™ — 3M Deutschland GmbH · Class I
- 3M™ — 3M Deutschland GmbH · Class I
- COE® Adhesive — Gc America Inc. · Class II
- 3M™ — 3M Deutschland GmbH · Class I
- 3M™ ESPE™ Impregum™ — 3M Deutschland GmbH · Class I
Cleared under the same submission
K102836 also covers:
- Defend — Young Innovations, Inc.
- Defend — Young Innovations, Inc.
- Defend — Young Innovations, Inc.
- Defend — Young Innovations, Inc.
- Defend — Young Innovations, Inc.
- Defend — Young Innovations, Inc.
- Defend — Young Innovations, Inc.
- Defend — Young Innovations, Inc.
- Defend — Young Innovations, Inc.
- Defend — Young Innovations, Inc.
- Defend — Young Innovations, Inc.
- Defend — Young Innovations, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Young Innovations, Inc.
Sources (1)
- FDA UDI 97963964-4452-44c5-aecb-732ad587d871 36 fields · synced Jun 8, 2026