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Premium UNIFY PGA Sutures

FDA UDI

Class II (US FDA UDI)

by Applied Dental, Inc.

Identity

Trade Name
Premium UNIFY PGA Sutures FDA UDI
Generic Name
Polyester suture, bioabsorbable, multifilament, non-antimicrobial FDA UDI
Device Name
Premium UNIFY PGA Sutures, Sm 5-0, 13mm 3/8 Circle Rev Cut, 18" Violet. FDA UDI
Model / Reference
PSG-518R13 FDA UDI
Description
Premium UNIFY PGA Sutures, Sm 5-0, 13mm 3/8 Circle Rev Cut, 18" Violet. FDA UDI

Identifiers

Primary DI / UDI-DI
00814639024944 FDA UDI
510(k) Number
K022664 FDA UDI
K073614 FDA UDI
K161629 FDA UDI
K200392 FDA UDI
FDA Product Code
GAM FDA UDI
GMDN Term
Polyester suture, bioabsorbable, multifilament, non-antimicrobial FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4493 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Polyester suture, bioabsorbable, multifilament, non-antimicrobial

Premium UNIFY PGA Sutures by Applied Dental, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Polyester suture, bioabsorbable, multifilament, non-antimicrobial.

Cleared under the same submission

K022664 also covers:

K073614 also covers:

K161629 also covers:

K200392 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Applied Dental, Inc.

Sources (1)

  • FDA UDI 669bb5cb-0e00-4e89-b02f-6bf9de6bf815 35 fields · synced Jun 8, 2026