Identity
- Trade Name
- ACE FDA UDI
- Generic Name
- Dental/maxillofacial surgical procedure kit, non-medicated, reusable FDA UDI
- Device Name
- Orthodontic Skeletal Anchorage Kit FDA UDI
- Model / Reference
- 4549250 FDA UDI
- Description
- Orthodontic Skeletal Anchorage Kit FDA UDI
Identifiers
- Catalog Number
- 4549250 FDA UDI
- Primary DI / UDI-DI
- 00614950008094 FDA UDI
- 510(k) Number
- K951392 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Dental/maxillofacial surgical procedure kit, non-medicated, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Radiation Sterilization FDA UDI
Dimensions & Sizes
- Size
- Length — 18 Millimeter FDA UDI
Category: Dental/maxillofacial surgical procedure kit, non-medicated, reusable
Ace by Ace Surgical Supply Co., Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental/maxillofacial surgical procedure kit, non-medicated, reusable.
- Dental Elevator Combo Set — SONTEC INSTRUMENTS, INC. · Class I
- Positioning Guide Full KIT — OSSTEM IMPLANT CO., LTD. · Class IIa
- Implantium, Superline — Dentium Co., Ltd. · Class I
- Bone Management — Hager & Meisinger Gesellschaft mit beschränkter Haftung · Class I
- Ditron Dental — DITRON DENTAL LTD · Class I
- KLOCKNER — SOADCO, S.L. · Class II
- HELMUT ZEPF — Helmut Zepf Medizintechnik GmbH · Class I
- Osteo KIT — OSSTEM IMPLANT Co., Ltd. · Class I
Cleared under the same submission
K951392 also covers:
- ACE — ACE SURGICAL SUPPLY CO., INC.
- ACE — ACE SURGICAL SUPPLY CO., INC.
- ACE — ACE SURGICAL SUPPLY CO., INC.
- ACE — ACE SURGICAL SUPPLY CO., INC.
- TRUFIX Bone Fixation System — ACE SURGICAL SUPPLY CO., INC.
- TRUFIX Bone Fixation System — ACE SURGICAL SUPPLY CO., INC.
- TRUFIX Bone Fixation System — ACE SURGICAL SUPPLY CO., INC.
- TRUFIX Bone Fixation System — ACE SURGICAL SUPPLY CO., INC.
- TRUFIX Bone Fixation System — ACE SURGICAL SUPPLY CO., INC.
- TRUFIX Bone Fixation System — ACE SURGICAL SUPPLY CO., INC.
- TRUFIX Bone Fixation System — ACE SURGICAL SUPPLY CO., INC.
- TRUFIX Bone Fixation System — ACE SURGICAL SUPPLY CO., 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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ace Surgical Supply Co., Inc.
Sources (1)
- FDA UDI a8351b98-4e2b-4875-a989-0a565d092592 37 fields · synced May 30, 2026