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FDA 510(k)

PRISMA-FIL COMPULES

K-Number: K812277 · 1981-09-08

ApplicantCaulk Co., Div. Dentsply
Decision Date1981-09-08
Product CodeEID
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PRISMA-FIL COMPULES is the device name listed in this FDA 510(k) record. The listed applicant is Caulk Co., Div. Dentsply. It received FDA 510(k) clearance on 1981-09-08 under 510(k) number K812277. The device is classified under product code EID. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRISMA-FIL COMPULES?

PRISMA-FIL COMPULES is a medical device that received FDA 510(k) clearance on 1981-09-08. The listed applicant is Caulk Co., Div. Dentsply. The 510(k) number is K812277.

When did PRISMA-FIL COMPULES receive FDA 510(k) clearance?

PRISMA-FIL COMPULES received FDA 510(k) clearance on 1981-09-08, under 510(k) number K812277.

Who is the listed applicant for PRISMA-FIL COMPULES?

The FDA 510(k) record lists Caulk Co., Div. Dentsply as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PRISMA-FIL COMPULES?

The FDA product code for PRISMA-FIL COMPULES is EID.

Related Clinical Trials

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Other records listing Caulk Co., Div. Dentsply as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K782080VENEER SYSTEM, MOSTIQUE LAMINATE

Related Devices (Code: EID)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K941431BONE GRAFT DELIVERY SYRINGESBio-Interfaces, Inc.K913974ACCESS IMPRESSION BARRELCentrix, Inc.K873153CAULK'S VPS CARTRIDGE SYSTEMDentsply Intl.K871937IMPRESSION SYRINGEDentsply Intl.K863998COLTENE JET-MIXERColtene, Inc.K853282CENTRIX RIBBON TUBESCentrix, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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