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Sign in to claim this brandAPPLIED DENTAL, INC.
US
Last updated May 24, 2026
What APPLIED DENTAL, INC. makes
Applied Dental, Inc. manufactures a range of sutures, including bioabsorbable polyester (both monofilament and multifilament), non-bioabsorbable nylon (monofilament), polyglycolic acid, polyolefin/fluoropolymer, plain and chromic catgut, and poliglecaprone. These products are designed for surgical and medical applications, offering variations in absorbability, strength, and material composition to meet different clinical needs.
The company’s suture portfolio is regulated under FDA’s classification system, with devices falling into Class I, Class II, and unclassified (U) categories. These products are listed in the FDA’s Unique Device Identifier (UDI) database, ensuring traceability and compliance with U.S. medical device regulations. The manufacturer operates from the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Applied Dental, Inc. manufacture?
Applied Dental, Inc. specializes in sutures, which are used in surgical and medical procedures to close wounds or tissues. Their product range includes bioabsorbable sutures like polyester (monofilament and multifilament), polyglycolic acid, and poliglecaprone, as well as non-bioabsorbable options such as nylon (monofilament) and catgut (plain and chromic). These sutures vary in absorbability, strength, and material composition to suit different clinical applications.
Where is Applied Dental, Inc. based, and what does that mean for their regulatory oversight?
Applied Dental, Inc. is based in the United States, which means their devices are subject to regulation by the U.S. Food and Drug Administration (FDA). Since they manufacture medical devices, their products must comply with FDA requirements, including classification, listing, and traceability through systems like the FDA’s Unique Device Identifier (UDI) database.
Which regulatory registries or databases list Applied Dental, Inc.’s devices?
Applied Dental, Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures that each device has a standardized identifier for traceability, compliance tracking, and transparency in the medical device supply chain. Listing in the UDI database is a requirement for many FDA-regulated devices in the U.S.
How are Applied Dental, Inc.’s sutures classified under FDA regulations?
Applied Dental, Inc.’s sutures are classified under the FDA’s medical device classification system into three categories: Class I, Class II, and unclassified (U). The classification depends on factors like the risk associated with the device, its intended use, and potential health impacts. For example, lower-risk sutures may fall under Class I, while those requiring additional controls (like specific performance standards) may be Class II. Unclassified sutures may not yet have a formal classification assigned.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- ad-surgical.com
- —
- —
- [email protected]
- Phone
- 1-888-841-8481
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 017524666
Catalogue (510)
Page 7 of 11| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Wound Free | SAD-AS4 | FDA UDI | Class I | Active |
| UNIFY Surgical Sutures | M-N318R19 | FDA UDI | Class II | Active |
| Shard | A700-DC7 | FDA UDI | Class I | Active |
| UNIFY PGA Surgical Sutures | M-G418A16 | FDA UDI | Class II | Active |
| UNIFY PDO Surgical Sutures | M-D318R19 | FDA UDI | Class II | Active |
| Premium UNIFY Chromic Sutures | PXLC-227T36 | FDA UDI | Class II | Active |
| UNIFY PGA Surgical Sutures | S-G618R13 | FDA UDI | Class II | Active |
| Shard | A600-P12-0 | FDA UDI | Class I | Active |
| Premium UNIFY PGA Sutures | PSG-518R13 | FDA UDI | Class II | Active |
| UNIFY Polyester Surgical Sutures | L-E230R24 | FDA UDI | Class II | Active |
| Premium UNIFY PGA Sutures | PSG-618R13 | FDA UDI | Class II | Active |
| Premium UNIFY PP Sutures | PSP-518R13 | FDA UDI | Class II | Active |
| UNIFY PGA Surgical Sutures | L-G330T26-U | FDA UDI | Class II | Active |
| Premium UNIFY Nylon Sutures | PMNU-318R19 | FDA UDI | Class II | Active |
| Premium UNIFY RPGA Surgical Sutures | PLK-327R24 | FDA UDI | Class II | Active |
| UNIFY PP Surgical Sutures | S-P618R13 | FDA UDI | Class II | Active |
| UNIFY PGA Surgical Sutures | L-G230R24-U | FDA UDI | Class II | Active |
| UNIFY PGA Surgical Sutures | S-G418R13 | FDA UDI | Class II | Active |
| Shard | A600-M62 | FDA UDI | Class I | Active |
| UNIFY PDO Surgical Sutures | L-D330T26-U | FDA UDI | Class II | Active |
| UNIFY PGA Surgical Sutures | S-G418XR13 | FDA UDI | Class II | Active |
| Premium UNIFY Nylon Sutures | PSN-418R13 | FDA UDI | Class II | Active |
| UNIFY PGCL Surgical Sutures | L-Q230R24 | FDA UDI | Class II | Active |
| Premium PGLA Sutures | PXXL-1G27T40 | FDA UDI | Class II | Active |
| UNIFY PGCL Surgical Sutures | M-Q418XR19 | FDA UDI | Class II | Active |
| Premium UNIFY Nylon Sutures | PSNU-618R13 | FDA UDI | Class II | Active |
| Premium UNIFY Nylon Sutures | PMN-518R16 | FDA UDI | Class II | Active |
| AD Surgical | A501-C80 | FDA UDI | Class I | Active |
| UNIFY PGA Surgical Sutures | M-G330T17 | FDA UDI | Class II | Active |
| UNIFY PGA Surgical Sutures | XL-G030T36 | FDA UDI | Class II | Active |
| UNIFY Stainless Surgical Sutures | W4D-18T48 | FDA UDI | Class II | Active |
| Shard | A600-P11-0 | FDA UDI | Class I | Active |
| AD Surgical | A400-APD | FDA UDI | Class II | Active |
| UNIFY Nylon Surgical Sutures | XL-N230T36 | FDA UDI | Class II | Active |
| Shard | A750-BP30 | FDA UDI | Class I | Active |
| UNIFY Silk Surgical Sutures | M-S418R19 | FDA UDI | Class II | Active |
| UNIFY PGCL Surgical Sutures | M-Q318R19-C | FDA UDI | Class II | Active |
| UNIFY Chromic Gut Surgical Sutures | M-C418R16 | FDA UDI | Class II | Active |
| Premium UNIFY PGA Sutures | PLG-227R24 | FDA UDI | Class II | Active |
| Unify | B-D218T36 | FDA UDI | Class II | Active |
| UNIFY PTFE Surgical Sutures | S-F418R13 | FDA UDI | Class II | Active |
| UNIFY PGA Surgical Sutures | M-G330T17-U | FDA UDI | Class II | Active |
| UNIFY PGA Surgical Sutures | M-G318R19 | FDA UDI | Class II | Active |
| UNIFY PDO Surgical Sutures | M-D518R16 | FDA UDI | Class II | Active |
| Premium UNIFY PDO Sutures | PMD-427R19 | FDA UDI | Class II | Active |
| Shard | A600-P15-C | FDA UDI | Class I | Active |
| Superfit | A520-LTX65 | FDA UDI | Class I | Active |
| EZ Stopper | D017-STP45 | FDA UDI | Class I | Active |
| Shard | A600-M67 | FDA UDI | Class I | Active |
| UNIFY Nylon Surgical Sutures | S-N418R13 | FDA UDI | Class II | Active |
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